An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

Last updated: January 14, 2020
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT02497469
MLN0002-3026
2015-000939-33
NL54690.056.15
U1111-1168-6713
  • Ages 18-85
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Has a diagnosis of ulcerative colitis established at least 3 months prior to screeningby clinical and endoscopic evidence and corroborated by a histopathology report.

  2. Has moderately to severely active ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days priorto the randomization.

  3. Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] ofinvolved colon).

  4. With extensive colitis (up to the hepatic flexure) or pancolitis of >8 years durationor left-sided colitis of >12 years duration must have documented evidence that asurveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during the Screening Period).

  5. The participant:

  6. Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha)antagonists without documented clinical response to treatment (example, due tolack of response [primary nonresponders], loss of response, or intolerance [secondary nonresponders]), or

  7. Has previously used a TNF-alpha antagonists (except adalimumab), and discontinuedits use due to reasons other than safety, or

  8. Is naïve to TNF-alpha antagonist therapy but is failing current treatment (example, corticosteroids, 5-aminosalicylate [5-ASA], or immunomodulators).

Exclusion

Exclusion Criteria:

  1. Clinical evidence of abdominal abscess or toxic megacolon at Screening.

  2. Has had an extensive colonic resection, subtotal or total colectomy.

  3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

  4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis,radiation colitis, diverticular disease associated with colitis, or microscopiccolitis.

  5. Has received any of the following for the treatment of underlying disease within 30days of randomization:

  6. Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) otherthan those specifically listed in Section Permitted Medications For Treatment ofUC.

  7. An approved non-biologic therapy in an investigational protocol.

  8. Has received any investigational or approved biologic or biosimilar agent within 60days or 5 half lives prior to the screening (whichever is longer).

  9. Has previously received natalizumab, efalizumab, adalimumab, AMG-181, anti-mucosaladdressin cell adhesion molecule-1 antibodies, or rituximab.

  10. Has previously received vedolizumab.

  11. Has history or evidence of adenomatous colonic polyps that have not been removed, orcolonic mucosal dysplasia.

  12. Evidence of an active infection during Screening.

  13. Evidence of, or treatment for, Clostridium difficile (C. difficile) or otherintestinal pathogen within 28 days prior to the 1st dose of study drug.

  14. Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV)infection (* HBV immune participants, ie, being hepatitis B surface antigen [HBsAg],may participate).

  15. Has active or latent TB, regardless of treatment history.

  16. Has used a topical (rectal) treatment with (5-ASA) or corticosteroidenemas/suppositories within 2 weeks of the administration of the 1st dose of studydrug.

  17. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptomchecklist prior to the administration of the first dose of study drug.

Study Design

Total Participants: 771
Study Start date:
June 29, 2015
Estimated Completion Date:
January 18, 2019

Study Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis. This study will look at the stool frequency, rectal bleeding and findings on endoscopy of people who take vedolizumab compared to those who take adalimumab.

The study will enroll approximately 658 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • Vedolizumab 300 mg IV

  • Adalimumab 160 mg on Day 1 followed by 80 mg on Week 2 then 40 mg every 2 weeks SC

All participants will receive 1 intravenous infusion on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. All participants will also receive 4 SC injections on Day 1 or 2 SC injections each on Days 1 and 2, followed by 2 SC injections in 1 day on Week 2 and then 1 SC injection every 2 weeks for up to Week 50. All participants will be asked to record the symptoms of ulcerative colitis in a daily diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 79 weeks. Participants will make approximately 11 visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.

Connect with a study center

  • Instituto de Investigaciones Clinicas-Mar del Plata

    Mar del Plata, Buenos Aires B7600FZ
    Argentina

    Site Not Available

  • Instituto Medico CER

    Quilmes, Buenos Aires B1878DVB
    Argentina

    Site Not Available

  • Centro de Investigaciones Clinicas Instituto del Corazon

    C0rdoba, Cordoba X5000EVQ
    Argentina

    Site Not Available

  • Centro de Investigaciones Clinicas Instituto del Corazon

    Córdoba, Cordoba X5000EVQ
    Argentina

    Site Not Available

  • Expertia S.A- Mautalen Salud e Investigacion

    Ciudad Autonoma Buenos Aires, C1128AAE
    Argentina

    Site Not Available

  • Centro de Investigaciones Clinicas Instituto del Corazon

    Cordoba, X5000EVQ
    Argentina

    Site Not Available

  • empty

    Bankstown, New South Wales
    Australia

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Mater Adult Hospital

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Tennyson Centre Day Hospital

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Ballarat Base Hospital

    Ballarat, Victoria 3350
    Australia

    Site Not Available

  • Monash Medical Centre Moorabbin

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • St Frances Xavier Cabrini Hospital

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • empty

    Perth, Western Australia
    Australia

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000
    Bosnia and Herzegovina

    Site Not Available

  • University Clinical Hospital Mostar

    Mostar, 88000
    Bosnia and Herzegovina

    Site Not Available

  • University Clinic Centre Sarajevo

    Sarajevo, 71000
    Bosnia and Herzegovina

    Site Not Available

  • MHAT - Pazardzhik AD

    Pazardzhik, 4400
    Bulgaria

    Site Not Available

  • MHAT 'Avis Medica' OOD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • MHAT "Hadzhi Dimitar", OOD

    Sliven, 8800
    Bulgaria

    Site Not Available

  • "City Clinic UMHAC" EOOD

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Fourth MHAT - Sofia EAD

    Sofia, 1606
    Bulgaria

    Site Not Available

  • Medical Center "Excelsior", OOD

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Military Medical Academy - MHAT - Sofia

    Sofia, 1606
    Bulgaria

    Site Not Available

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • UMHAT 'Sveta Anna' AD

    Sofia, 1750
    Bulgaria

    Site Not Available

  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD

    Sofia, 1527
    Bulgaria

    Site Not Available

  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • MHAT 'Sv. Marina', EAD

    Varna, 9020
    Bulgaria

    Site Not Available

  • empty

    Calgary, Alberta
    Canada

    Site Not Available

  • University of Alberta

    Edmonton, Alberta T6G 2X8
    Canada

    Site Not Available

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    Abbotsford, British Columbia
    Canada

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    Vancouver, British Columbia
    Canada

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    St. John's, Newfoundland and Labrador
    Canada

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  • McMaster University Health Sciences Center

    Hamilton, Ontario L8N3Z5
    Canada

    Site Not Available

  • Hotel Dieu Hospital

    Kingston, Ontario K7L 5G2
    Canada

    Site Not Available

  • LHSC - University Hospital

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • LHSC - Victoria Hospital

    London, Ontario N6A 5W9
    Canada

    Site Not Available

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    North York, Ontario
    Canada

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    Oakville, Ontario
    Canada

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    Ottawa, Ontario
    Canada

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    Toronto, Ontario
    Canada

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  • Toronto Digestive Disease Associates, Inc.

    Vaughan, Ontario L4L 4Y7
    Canada

    Site Not Available

  • McGill University Health Centre/Glen Site / Royal Victoria Hospital

    Montreal, Quebec H3A 1A1
    Canada

    Site Not Available

  • Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal

    Montréal, Quebec H1T 2M4
    Canada

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  • Royal University Hospital

    Saskatoon, Saskatchewan S7N 0W8
    Canada

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    Quebec,
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    Santiago,
    Chile

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    Vina del Mar,
    Chile

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    Bucaramanga,
    Colombia

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  • Fundacion Oftalmologica de Santander - FOSCAL

    Floridablanca, 681004
    Colombia

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  • Instituto de Coloproctologia ICO S.A.S.

    Medellin, 050025
    Colombia

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  • Clinical Hospital Centre Osijek

    Osijek, 31000
    Croatia

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  • General Hospital Pula

    Pula, 52100
    Croatia

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  • Polyclinic Medico

    Rijeka, 51000
    Croatia

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    Zagreb, 10000
    Croatia

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    Zagreb, 10000
    Croatia

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  • Clinical Hospital Dubrava

    Zagreb, 10000
    Croatia

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  • Clinical Hospital Merkur

    Zagreb, 10000
    Croatia

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  • empty

    Praha 4,
    Czech Republic

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    Tabor,
    Czech Republic

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  • CCBR - Brno - CZ

    Brno, 60200
    Czechia

    Site Not Available

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 65691
    Czechia

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  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Kralove, 500 12
    Czechia

    Site Not Available

  • CCBR Czech, a.s

    Pardubice, 530 02
    Czechia

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  • A-Shine

    Plzen, 31200
    Czechia

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  • CCBR - Prague - CZ

    Praha 3, 13000
    Czechia

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  • Thomayerova nemocnice

    Praha 4 - Krc, 140 59
    Czechia

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  • Klinicke centrum ISCARE Lighthouse

    Praha 7, 17004
    Czechia

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  • Axon Clinical, s.r.o.

    Praha 8, 182 00
    Czechia

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  • Nordsjallands Hospital, Frederikssund

    Frederikssund, 3600
    Denmark

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    Hillerod,
    Denmark

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  • Hvidovre_Hospital

    Hvidovre, 2650
    Denmark

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  • Koge Sygehus

    Koge, 4600
    Denmark

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  • Køge Sygehus

    Køge, 4600
    Denmark

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  • Odense Universitetshospital

    Odense C, 5000
    Denmark

    Site Not Available

  • North Estonia Medical Centre Foundation

    Tallinn, 13419
    Estonia

    Site Not Available

  • West Tallinn Central Hospital

    Tallinn, 10617
    Estonia

    Site Not Available

  • Tartu University Hospital

    Tartu, 50406
    Estonia

    Site Not Available

  • empty

    HUS,
    Finland

    Site Not Available

  • empty

    Tampere,
    Finland

    Site Not Available

  • CHU Nice - Hopital de l'Archet 2

    Nice Cedex 3, Alpes Maritimes 06200
    France

    Site Not Available

  • Hopital Saint Joseph

    Marseille, Bouches-du-Rhone 13008
    France

    Site Not Available

  • Hopital Nord - CHU Marseille

    Marseille cedex 20, Bouches-du-Rhone 13915
    France

    Site Not Available

  • Groupe Hospitalier Sud - Hopital Haut-Leveque

    Pessac, Gironde 33604
    France

    Site Not Available

  • CHU de Toulouse - Hopital Rangueil

    Toulouse Cedex 09, Haute Garonne 31059
    France

    Site Not Available

  • Hopital Beaujon

    Clichy cedex, Hauts De Seine 92110
    France

    Site Not Available

  • CHU Saint Etienne - Hopital Nord

    Saint Etienne, Loire 42055
    France

    Site Not Available

  • Hopital de Brabois Adultes

    Vandoeuvre les Nancy, Meurthe Et Moselle 54511
    France

    Site Not Available

  • Hopital Claude Huriez - CHU Lille

    Lille cedex, Nord 59037
    France

    Site Not Available

  • CHU Amiens - Hopital Sud

    Amiens Cedex, Somme 80054
    France

    Site Not Available

  • Centre Hospitalier Departemental Les Oudairies

    La Roche S/ Yon Cedex 9, Vendee 85925
    France

    Site Not Available

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden Wuerttemberg 69120
    Germany

    Site Not Available

  • empty

    Stuttgart, Baden Wuerttemberg
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen

    Tuebingen, Baden Wuerttemberg 72076
    Germany

    Site Not Available

  • empty

    Muenchen, Bayern
    Germany

    Site Not Available

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Koeln, Nordrhein Westfalen 50937
    Germany

    Site Not Available

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, Rheinland Pfalz 55131
    Germany

    Site Not Available

  • EUGASTRO GmbH

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Universitaetsklinikum Magdeburg A.oe.R

    Magdeburg, Sachsen Anhalt 39120
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, Schleswig Holstein 24105
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lubeck, Schleswig Holstein 23538
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, Schleswig Holstein 23538
    Germany

    Site Not Available

  • Charite - Campus Virchow-Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Krankenhaus Waldfriede e. V.

    Berlin, 141 63
    Germany

    Site Not Available

  • Asklepios Klinik Hamburg

    Hamburg, 22559
    Germany

    Site Not Available

  • The University of Hong Kong

    Hong Kong,
    Hong Kong

    Site Not Available

  • Tuen Mun Hospital

    Medicine & Geriatrics, 00000
    Hong Kong

    Site Not Available

  • The Chinese University of Hong Kong

    Shatin, 00000
    Hong Kong

    Site Not Available

  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

    Bekescsaba, 5600
    Hungary

    Site Not Available

  • Pannonia Maganorvosi Centrum

    Budapest, 1136
    Hungary

    Site Not Available

  • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont

    Budapest, 1076
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1083
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, 3300
    Hungary

    Site Not Available

  • Pecsi Tudomanyegyetem

    Pecs, 7624
    Hungary

    Site Not Available

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6720
    Hungary

    Site Not Available

  • Tolna Megyei Balassa Janos Korhaz

    Szekszard, 7100
    Hungary

    Site Not Available

  • HaEmek Medical Center

    Afula, 18101
    Israel

    Site Not Available

  • Barzilai Medical Center

    Ashkelon, 78278
    Israel

    Site Not Available

  • Hillel Yaffe Medical

    Hadera, 3810101
    Israel

    Site Not Available

  • Wolfson Medical Center

    Holon, 58100
    Israel

    Site Not Available

  • Clalit Health Services-Lev Talpiyot

    Jerusalem, 9362410
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 91031
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar- Saba, 4428164
    Israel

    Site Not Available

  • Galilee Medical Center

    Nahariya, 22100
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rechovot, 7610001
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia 71013
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese, Milano 20097
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedale Cannizzaro

    Catania, 95100
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, 50141
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria San Martino

    Genova, 16132
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico G. Martino

    Messina, 98125
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

    Milano, 20157
    Italy

    Site Not Available

  • A.O.U. Policlinico di Modena

    Modena, 41124
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria "Federico II"

    Napoli, 80131
    Italy

    Site Not Available

  • Seconda Universita degli Studi di Napoli

    Napoli, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova

    Padova, 35128
    Italy

    Site Not Available

  • Azienda Ospedaliera Vincenzo Cervello

    Palermo, 90146
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127
    Italy

    Site Not Available

  • empty

    Parma,
    Italy

    Site Not Available

  • empty

    Pavia,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124
    Italy

    Site Not Available

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00152
    Italy

    Site Not Available

  • Hanyang Univerisy Guri Hospital

    Guri-si, Gyeonggi-do 11923
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon-si, Gyeonggi-do 16247
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Daegu, Gyeongsangbuk-do 700-721
    Korea, Republic of

    Site Not Available

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    Busan, 49241
    Korea, Republic of

    Site Not Available

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    Daegu, 42415
    Korea, Republic of

    Site Not Available

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    Seoul, 05505
    Korea, Republic of

    Site Not Available

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    Seoul, 03181
    Korea, Republic of

    Site Not Available

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    Seoul, 02841
    Korea, Republic of

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    Seoul, 02447
    Korea, Republic of

    Site Not Available

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    Seoul, 06351
    Korea, Republic of

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    Seoul, 03080
    Korea, Republic of

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    Seoul, 03722
    Korea, Republic of

    Site Not Available

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    Seoul, 06591
    Korea, Republic of

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  • Digestive Diseases Center "Gastro"

    Riga, LV-1006
    Latvia

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    Riga, LV1002
    Latvia

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  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, 50009
    Lithuania

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    Klaipeda, 92231
    Lithuania

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    Klaipeda, 92288
    Lithuania

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  • Vilnius University Hospital Santariskiu Clinic, Public Institution

    Vilnius, LT-08661
    Lithuania

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  • Centro de Investigacion Farmacologica del Bajio, S.C.

    Leon, Guanajuato 37520
    Mexico

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  • Morales Vargas Centro de Investigacion, S.C.

    Leon, Guanajuato 37000
    Mexico

    Site Not Available

  • Christus Muguerza Sur S.A. de C.V.

    Monterrey, Nuevo Leon 64908
    Mexico

    Site Not Available

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000
    Mexico

    Site Not Available

  • Sociedad de Metabolismo y Corazon S.C

    Veracruz, 91910
    Mexico

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  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ
    Netherlands

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    Amsterdam, 1091 AC
    Netherlands

    Site Not Available

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    Groningen, 9713 GZ
    Netherlands

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    Maastricht, 6202 AZ
    Netherlands

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    Rotterdam, 3015 CE
    Netherlands

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    Oslo,
    Norway

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  • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

    Bialystok, 15-275
    Poland

    Site Not Available

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    Bydgoszcz, 85-079
    Poland

    Site Not Available

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    Gdansk, 80-952
    Poland

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    Katowice, 40-752
    Poland

    Site Not Available

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, 31-009
    Poland

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    Lodz, 90-153
    Poland

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    Lodz, 90-302
    Poland

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    Lublin, 20-582
    Poland

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    Poznan, 60-529
    Poland

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  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny MSW w Warszawie

    Warszawa, 02-507
    Poland

    Site Not Available

  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

    Warszawa, 02-781
    Poland

    Site Not Available

  • Centrum Zdrowia Matki, Dziecka i Mlodziezy

    Warszawa, 00-632
    Poland

    Site Not Available

  • Nzoz Vivamed

    Warszawa, 03-580
    Poland

    Site Not Available

  • Ars-Medica S.C Rybak Maria, Rybak Zbigniew

    Wroclaw, 53-333
    Poland

    Site Not Available

  • EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu

    Wroclaw, 54-144
    Poland

    Site Not Available

  • LexMedica Osrodek Badan Klinicznych

    Wroclaw, 53-114
    Poland

    Site Not Available

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Site Not Available

  • Centro Hospitalar e Universitario de Coimbra E.P.E

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Centro Hospitalar Cova da Beira

    Covilha, 6200-502
    Portugal

    Site Not Available

  • Hospital da Senhora da Oliveira Guimar es

    Guimar es, 4835-044
    Portugal

    Site Not Available

  • Hospital da Senhora da Oliveira Guimaraes

    Guimaraes, 4835-044
    Portugal

    Site Not Available

  • Hospital da Senhora da Oliveira Guimarães

    Guimarães, 4835-044
    Portugal

    Site Not Available

  • empty

    Lisboa,
    Portugal

    Site Not Available

  • Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE

    Viana do Castelo, 4904-858
    Portugal

    Site Not Available

  • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

    Vila Nova de Gaia, 4434-502
    Portugal

    Site Not Available

  • Institutul Clinic Fundeni

    Bucuresti, 022328
    Romania

    Site Not Available

  • Spitalul Clinic Colentina

    Bucuresti, 020125
    Romania

    Site Not Available

  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

    Timisoara, 300002
    Romania

    Site Not Available

  • SBEI HPE "Kazan State Medical University" of the MoH of the RF

    Kazan, 420012
    Russian Federation

    Site Not Available

  • TSBIH "Territorial Clinical Hospital"

    Krasnoyarsk, 660022
    Russian Federation

    Site Not Available

  • FSBI State Scientific Centre of Coloproctology" of the MoH of RF

    Moscow, 123154
    Russian Federation

    Site Not Available

  • FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

    Moscow, 119333
    Russian Federation

    Site Not Available

  • Research Institute of Gastroenterology

    Moscow, 111123
    Russian Federation

    Site Not Available

  • SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

    Nizhny Novgorod, 603126
    Russian Federation

    Site Not Available

  • FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS

    Novosibirsk, 630117
    Russian Federation

    Site Not Available

  • SBEIHPE Novosibirsk State Medical University

    Novosibirsk, 630091
    Russian Federation

    Site Not Available

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013
    Russian Federation

    Site Not Available

  • SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF

    Omsk, 644099
    Russian Federation

    Site Not Available

  • SBEI HPE "Rostov State Medical University" of the MoH of the RF

    Rostov-on-Don, 344022
    Russian Federation

    Site Not Available

  • FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia

    Saint-Petersburg, 194044
    Russian Federation

    Site Not Available

  • SPb SBIH "City Hospital # 26"

    Saint-Petersburg, 196247
    Russian Federation

    Site Not Available

  • SPb SBIH "City Hospital # 9"

    Saint-Petersburg, 197110
    Russian Federation

    Site Not Available

  • Private Educational Institution of Higher Education "Medical University "REAVIZ"

    Samara, 443115
    Russian Federation

    Site Not Available

  • SIH "Regional Clinical Hospital "

    Saratov, 410053
    Russian Federation

    Site Not Available

  • SPb SBIH "City Hospital # 40 of Kurortnyi region"

    Sestroretsk, 197706
    Russian Federation

    Site Not Available

  • RSBIH "Smolensk Regional Clinical Hospital"

    Smolensk, 214019
    Russian Federation

    Site Not Available

  • SPb SBIH "City Hospital of Saint Martyr Elizaveta"

    St. Petersburg, 195257
    Russian Federation

    Site Not Available

  • SBIH of Yaroslavl region " Regional Clinical Hospital "

    Yaroslavl, 150062
    Russian Federation

    Site Not Available

  • Clinical Center Bezanijska kosa

    Belgrade, 11080
    Serbia

    Site Not Available

  • Clinical Center Zemun

    Belgrade, 11080
    Serbia

    Site Not Available

  • Clinical Center Zvezdara

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Center of Serbia

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Clinical Center Nis

    Nis, 18000
    Serbia

    Site Not Available

  • Clinical Center of Vojvodina

    Novi Sad, 21000
    Serbia

    Site Not Available

  • IBDcentrum s.r.o.

    Bratislava, 81108
    Slovakia

    Site Not Available

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

    Bratislava, 82606
    Slovakia

    Site Not Available

  • Gastroped s.r.o.

    Kosice, 04001
    Slovakia

    Site Not Available

  • KM Management spol. s r.o.

    Nitra, 949 01
    Slovakia

    Site Not Available

  • Gastro I, s.r.o.

    Presov, 080 01
    Slovakia

    Site Not Available

  • Frantisek Horvath- GEA

    Sahy, 936 01
    Slovakia

    Site Not Available

  • empty

    Johannesburg, Gauteng
    South Africa

    Site Not Available

  • empty

    Durban, KwaZulu-Natal
    South Africa

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • empty

    Santiago de Compostela, La Coruna
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • empty

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • empty

    Sevilla,
    Spain

    Site Not Available

  • empty

    Stockholm,
    Sweden

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung, 402
    Taiwan

    Site Not Available

  • Mackay Memorial Hospital

    Taipei, 10449
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Ankara University Medical Faculty

    Ankara, 06100
    Turkey

    Site Not Available

  • Acibadem Fulya Hospital

    Istanbul, 34349
    Turkey

    Site Not Available

  • Haydarpasa Numune Training and Research Hospital

    Istanbul, 34668
    Turkey

    Site Not Available

  • Marmara University Pendik Research and Training Hospital

    Istanbul, 34899
    Turkey

    Site Not Available

  • Kocaeli Derince Training and Research Hospital

    Kocaeli, 41380
    Turkey

    Site Not Available

  • Mersin University Medical Faculty

    Mersin, 33343
    Turkey

    Site Not Available

  • RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

    Chernivtsi, 58002
    Ukraine

    Site Not Available

  • SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU

    Dnipropetrovsk, 49074
    Ukraine

    Site Not Available

  • Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU

    Ivano-Frankivsk, 76008
    Ukraine

    Site Not Available

  • CI of PH Kharkiv CCH #2

    Kharkiv, 61037
    Ukraine

    Site Not Available

  • CI A.and O. Tropiny City Clinical Hospital

    Kherson, 73000
    Ukraine

    Site Not Available

  • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

    Kirovohrad, 25006
    Ukraine

    Site Not Available

  • CI of Kyiv RC Kyiv Regional Clinical Hospital

    Kyiv, 01023
    Ukraine

    Site Not Available

  • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU

    Kyiv, 01103
    Ukraine

    Site Not Available

  • Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE

    Kyiv, 04201
    Ukraine

    Site Not Available

  • MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE

    Kyiv, 01023
    Ukraine

    Site Not Available

  • CI of TRC Ternopil University Hospital

    Lviv, 46002
    Ukraine

    Site Not Available

  • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU

    Lviv, 79059
    Ukraine

    Site Not Available

  • CI Odesa Regional Clinical Hospital

    Odesa, 65025
    Ukraine

    Site Not Available

  • empty

    Ternopil,
    Ukraine

    Site Not Available

  • SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU

    Uzhgorod, 88009
    Ukraine

    Site Not Available

  • MCIC MC LLC Health Clinic

    Vinnytsia, 21029
    Ukraine

    Site Not Available

  • Private Small Enterprise Medical Center Pulse

    Vinnytsia, 21001
    Ukraine

    Site Not Available

  • SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

    Vinnytsia, 21029
    Ukraine

    Site Not Available

  • Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU

    Vinnytsia, 21005
    Ukraine

    Site Not Available

  • CI City Clinical Hospital #6 Dept of Gastroenterology

    Zaporizhzhia, 69035
    Ukraine

    Site Not Available

  • SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU

    Zaporizhzhia, 69104
    Ukraine

    Site Not Available

  • Derriford Hospital

    Plymouth, Devon PL6 5FP
    United Kingdom

    Site Not Available

  • empty

    Manchester, Greater Manchester
    United Kingdom

    Site Not Available

  • Salford Royal

    Salford, Greater Manchester M6 8HD
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk NR47UY
    United Kingdom

    Site Not Available

  • Glasgow Royal Infirmary

    Glasgow, Strathclyde G4 0SF
    United Kingdom

    Site Not Available

  • University Hospital Coventry

    Coventry, West Midlands CV2 2DX
    United Kingdom

    Site Not Available

  • Royal Wolverhampton hospital

    Wolverhampton, West Midlands WV10 0QP
    United Kingdom

    Site Not Available

  • IMC - Diagnostic and Medical Clinic

    Mobile, Alabama 36604
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona 85037
    United States

    Site Not Available

  • empty

    Tucson, Arizona
    United States

    Site Not Available

  • Arkansas Primary Care Clinic, PA

    Little Rock, Arkansas 72204
    United States

    Site Not Available

  • empty

    Corona, California
    United States

    Site Not Available

  • WCCT Global (PH 1 Unit)

    Costa Mesa, California 92626
    United States

    Site Not Available

  • empty

    Cypress, California
    United States

    Site Not Available

  • empty

    La Jolla, California
    United States

    Site Not Available

  • empty

    Long Beach, California
    United States

    Site Not Available

  • empty

    Los Angeles, California
    United States

    Site Not Available

  • empty

    Mission Hills, California
    United States

    Site Not Available

  • California Medical Research Associates Inc.

    Northridge, California 91324
    United States

    Site Not Available

  • Sutter Institute for Medical Research

    Sacramento, California 95816
    United States

    Site Not Available

  • empty

    Santa Clarita, California
    United States

    Site Not Available

  • empty

    Torrance, California
    United States

    Site Not Available

  • Rocky Mountain Gastroenterology

    Lakewood, Colorado 80214-5434
    United States

    Site Not Available

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • empty

    Hartford, Connecticut
    United States

    Site Not Available

  • empty

    Middletown, Connecticut
    United States

    Site Not Available

  • Innovative Medical Research of South Florida, Inc.

    Aventura, Florida 33180
    United States

    Site Not Available

  • empty

    Coral Gables, Florida
    United States

    Site Not Available

  • Advanced Clinical Research of Miami

    Doral, Florida 33172
    United States

    Site Not Available

  • Wellness Clinical Research

    Hialeah Gardens, Florida 33016
    United States

    Site Not Available

  • Nature Coast Clinical Research, LLC

    Inverness, Florida 34452
    United States

    Site Not Available

  • Florida Center for Gastroenterology

    Largo, Florida 33773-1615
    United States

    Site Not Available

  • Gastro Health

    Miami, Florida 33143
    United States

    Site Not Available

  • Medical Professional Clinical Research

    Miami, Florida 33165
    United States

    Site Not Available

  • Tellus Clinical Research, Inc.

    Miami, Florida 33173
    United States

    Site Not Available

  • South Florida Research Phase I-IV

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Gastroenterology Group of Naples

    Naples, Florida 34102
    United States

    Site Not Available

  • Internal Medicine Specialists

    Orlando, Florida 32806
    United States

    Site Not Available

  • BRCR Medical Center, Inc.

    Plantation, Florida 33322
    United States

    Site Not Available

  • Clinical Research Center of Florida

    Pompano Beach, Florida 33060
    United States

    Site Not Available

  • empty

    Weston, Florida
    United States

    Site Not Available

  • Shafran Gastroenterology Center

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • empty

    Decatur, Georgia
    United States

    Site Not Available

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia 31201
    United States

    Site Not Available

  • empty

    Marietta, Georgia
    United States

    Site Not Available

  • empty

    Suwanee, Georgia
    United States

    Site Not Available

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • empty

    Evansville, Indiana
    United States

    Site Not Available

  • empty

    Indianapolis, Indiana
    United States

    Site Not Available

  • Gastroenterology of Southern Associates

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Iowa Digestive Disease Center

    Clive, Iowa 50325
    United States

    Site Not Available

  • Cotton-O'Neil Clinical Research Center, Digestive Health

    Topeka, Kansas 66606
    United States

    Site Not Available

  • empty

    Beaver Dam, Kentucky
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Research Concierge, LLC

    Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Lafayette General Medical Center

    Lafayette, Louisiana 70503
    United States

    Site Not Available

  • empty

    Metaire, Louisiana
    United States

    Site Not Available

  • Clinical Trials Management, LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Louisiana Research Center, LLC

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • empty

    Baltimore, Maryland
    United States

    Site Not Available

  • empty

    Cantonsville, Maryland
    United States

    Site Not Available

  • Digestive Disease Associates

    Catonsville, Maryland 21228
    United States

    Site Not Available

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • empty

    Boston, Massachusetts
    United States

    Site Not Available

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Center for Digestive Health and Nutritional Excellence

    Troy, Michigan 48098
    United States

    Site Not Available

  • Gastroenterology Associates of Western Michigan, P.L.C.

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Digestive Health Center PA

    Ocean Springs, Mississippi 39564
    United States

    Site Not Available

  • Ehrhardt Clinical Research, LLC

    Belton, Missouri 64012
    United States

    Site Not Available

  • Truman Medical Centers, Inc.

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • empty

    Omah, Nebraska
    United States

    Site Not Available

  • Alegent Creighton Clinic Gastroenterology

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • AGA Clinical Research Associates, LLC

    Egg Harbor City, New Jersey 08234
    United States

    Site Not Available

  • AGA Clinical Research Associates, LLC

    Egg Harbor Township, New Jersey 08234
    United States

    Site Not Available

  • Long Island Clinical Research Associates

    Great Neck, New York 11021
    United States

    Site Not Available

  • Mount Sinai - PRIME

    Lake Success, New York 10029
    United States

    Site Not Available

  • Digestive Disease Care

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Site Not Available

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599-7080
    United States

    Site Not Available

  • Consultants for Clinical Research Inc.

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Ohio State University Clinical Trials Management Office

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Dayton Gastroenterology, Inc

    Dayton, Ohio 45415
    United States

    Site Not Available

  • Gastro-Enterology Research of Lima

    Lima, Ohio 45806
    United States

    Site Not Available

  • Options Health Research

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • The Oregon Clinic-West Hills Gastroenterology

    Portland, Oregon 97225
    United States

    Site Not Available

  • Main Line Gastroenterology Associates

    Malvern, Pennsylvania 19355
    United States

    Site Not Available

  • empty

    Paoli, Pennsylvania
    United States

    Site Not Available

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Invocare Clinical Research Center

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212-1375
    United States

    Site Not Available

  • empty

    Austin, Texas
    United States

    Site Not Available

  • Baylor University Hospital

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Digestive Disease Consultants - Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • MedResearch, Inc

    El Paso, Texas 79935
    United States

    Site Not Available

  • Gastroenterology Consultants of South Texas, PA

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Gulf Coast Research Group LLC

    Houston, Texas 77098
    United States

    Site Not Available

  • Texas Digestive Disease Consultants - Irving

    Irving, Texas 75039
    United States

    Site Not Available

  • Advanced Clinical Research Associates

    Plano, Texas 75093
    United States

    Site Not Available

  • Gastroenterology Research of San Antonio, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Texas Digestive Disease Consultants - Southlake

    Southlake, Texas 76092
    United States

    Site Not Available

  • Digestive Health Specialists of Tyler

    Tyler, Texas 75701
    United States

    Site Not Available

  • Aspen Clinical Research

    Orem, Utah 84058
    United States

    Site Not Available

  • empty

    Ashburn, Virginia
    United States

    Site Not Available

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia 23320
    United States

    Site Not Available

  • Virginia Mason Seattle Main Clinic

    Seattle, Washington 98101
    United States

    Site Not Available

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53705
    United States

    Site Not Available

  • Allegiance Research Specialists, LLC

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • empty

    Wauwatosa, Wisconsin
    United States

    Site Not Available

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