Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

Last updated: November 5, 2021
Sponsor: Ferring Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Crohn's Disease

Ulcers

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

NCT02522780
000175
2015-002558-11
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC. The duration of treatment for each subject was 6 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission

Exclusion

Exclusion Criteria:

  • Evidence of other forms of inflammatory bowel disease
  • Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
  • Disease limited to proctitis <15 cm
  • Short bowel syndrome
  • Prior colon resection surgery
  • History of severe/fulminant UC
  • Intolerant or allergic to aspirin or salicylate derivatives
  • Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days
  • Women who are pregnant or nursing
  • History of known malignancy
  • History of bleeding disorders, active gastric or active duodenal ulcers, autoimmunediseases, or mental/ emotional disorders, that would interfere with theirparticipation in the trial

Study Design

Total Participants: 276
Study Start date:
February 01, 2016
Estimated Completion Date:
September 19, 2018

Connect with a study center

  • Onze-Lieve-Vrouwziekenhuis Institute

    Aalst,
    Belgium

    Site Not Available

  • Multiprofile Hospital For Active Treatment Avis Medica

    Pleven,
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Kaspela

    Plovdiv,
    Bulgaria

    Site Not Available

  • Medical Center Excelsior OOD

    Sevlievo,
    Bulgaria

    Site Not Available

  • Medical Center-1-Sevlievo EOOD

    Sevlievo,
    Bulgaria

    Site Not Available

  • City Clinic University Multiprofile Hospital for Active Treatment EOOD

    Sofia,
    Bulgaria

    Site Not Available

  • Medical Center Asklepion - Humane Medicine Research EOOD

    Sofia,
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

    Sofia,
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia,
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Centre Mladost M OOD

    Varna,
    Bulgaria

    Site Not Available

  • Topstone Research Institute

    Ottawa, Ontario
    Canada

    Site Not Available

  • Sudbury Endoscopy Centre

    Sudbury, Ontario
    Canada

    Site Not Available

  • Toronto Digestive Disease Associates Inc

    Toronto, Vaughan
    Canada

    Site Not Available

  • Mackenzie Richmond Hill Hospital

    Richmond Hill,
    Canada

    Site Not Available

  • Magyar Honvédség Egészségügyi Központ

    Budapest,
    Hungary

    Site Not Available

  • Pannónia Magánorvosi Centrum Kft

    Budapest,
    Hungary

    Site Not Available

  • Semmelweis Egyetem Institute

    Budapest,
    Hungary

    Site Not Available

  • Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja

    Debrecen,
    Hungary

    Site Not Available

  • Szent Pantaleon Kórház Kht

    Dunaújváros,
    Hungary

    Site Not Available

  • ENDOMEDIX Kft.

    Miskolc,
    Hungary

    Site Not Available

  • Karolina Korhaz Rendelointezet

    Mosonmagyarovar,
    Hungary

    Site Not Available

  • Clinfan Kft.

    Szekszard,
    Hungary

    Site Not Available

  • Polana-D, LTD

    Daugavpils,
    Latvia

    Site Not Available

  • Digestive Diseases Centre Gastro

    Riga,
    Latvia

    Site Not Available

  • Latvian Maritime Medicine Centre

    Riga,
    Latvia

    Site Not Available

  • Pauls Stradins Clinical University Hospital

    Riga,
    Latvia

    Site Not Available

  • Riga East Clinical University Hospital

    Riga,
    Latvia

    Site Not Available

  • ICARO Investigaciones en Medicina, S.A de C.V

    Chihuahua,
    Mexico

    Site Not Available

  • Maria Auxiliadora Hospital

    Guadalajara,
    Mexico

    Site Not Available

  • Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.

    Zapopan,
    Mexico

    Site Not Available

  • Osrodek Medycyny Rodzinnej Sp. z o.o.

    Sobótka, Dolnoslaskie
    Poland

    Site Not Available

  • Lexmedica

    Wroclaw, Dolnoslaskie
    Poland

    Site Not Available

  • Zespół Przychodni Specjalistycznych PRIMA Sp. z o.o.

    Warszawa, Mazowieckie
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomorskie
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej Intermed

    Czestochowa,
    Poland

    Site Not Available

  • Economicus - NZOZ ALL-MEDICUS

    Katowice,
    Poland

    Site Not Available

  • Investigational site

    Ksawerow,
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

    Lodz,
    Poland

    Site Not Available

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz,
    Poland

    Site Not Available

  • Endoskopia Sp. z o.o.

    Sopot,
    Poland

    Site Not Available

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw,
    Poland

    Site Not Available

  • Regional Clinical Hospital

    Krasnoyarsk,
    Russian Federation

    Site Not Available

  • City Clinical Hospital # 51

    Moscow,
    Russian Federation

    Site Not Available

  • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

    Nizhny Novgorod,
    Russian Federation

    Site Not Available

  • Novosibirsk State Medical University

    Novosibirsk,
    Russian Federation

    Site Not Available

  • Research Institute of Physiology of Sibirian Branch the RAMS

    Novosibirsk,
    Russian Federation

    Site Not Available

  • Omsk State Medical Academy

    Omsk,
    Russian Federation

    Site Not Available

  • Rostov State Medical University

    Rostov-on-Don,
    Russian Federation

    Site Not Available

  • Ryazan Regional Clinical Hospital

    Ryazan,
    Russian Federation

    Site Not Available

  • State Budget Institution of Ryazan region" Regional Clinical Hospital"

    Ryazan,
    Russian Federation

    Site Not Available

  • City Hospital #31

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Russian Medical Military Academy n.a. S.M. Kirov

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Medical Company "Hepatolog", LLC

    Samara,
    Russian Federation

    Site Not Available

  • City Polyclinic #38

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Stavropol State Medical Academy

    Stavropol,
    Russian Federation

    Site Not Available

  • Clinical Hospital Centar Zvezdara

    Belgrade,
    Serbia

    Site Not Available

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade,
    Serbia

    Site Not Available

  • Health Center Valjevo

    Valjevo,
    Serbia

    Site Not Available

  • Inselspital Bern

    Bern,
    Switzerland

    Site Not Available

  • Investigational site

    Bern,
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich,
    Switzerland

    Site Not Available

  • Medical Center LLC Ukrainian German Antiulcer Gastroenterology Center BIK Kyiv

    Kyiv, Kyïv
    Ukraine

    Site Not Available

  • Regional Municipal Institution Chernivtsi Regional Clinical Hospital

    Chernivtsi,
    Ukraine

    Site Not Available

  • Municipal Institution Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov

    Dnipropetrovsk,
    Ukraine

    Site Not Available

  • Municipal Healthcare Institution Kharkiv City Clinical Hospital #2

    Kharkiv,
    Ukraine

    Site Not Available

  • SI National Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine

    Kharkiv,
    Ukraine

    Site Not Available

  • Municipal Intitution "Kherson City Clinical Hospital n.a. A. and O. Tropinykh"

    Kherson,
    Ukraine

    Site Not Available

  • Private Enterprise Private Manufactire Company "Acinus"

    Kirovograd,
    Ukraine

    Site Not Available

  • Private Enterprise Private Manufactire Company "Acinus"

    Kirovohrad,
    Ukraine

    Site Not Available

  • Kremenchuk city Hospital # n.a O.T.Bohaievskyi

    Kremenchuk,
    Ukraine

    Site Not Available

  • Kyiv City Clinical Hospital #8

    Kyiv,
    Ukraine

    Site Not Available

  • Kyiv Municipal Clinical Hospital #18

    Kyiv,
    Ukraine

    Site Not Available

  • Medical Center Universal Clinic Oberih of LLC Kapytal

    Kyiv,
    Ukraine

    Site Not Available

  • Municipal City Clinical emergency Hospital

    Lviv,
    Ukraine

    Site Not Available

  • Municipal Institution Odesa Regional Clinical Hospital

    Odesa,
    Ukraine

    Site Not Available

  • Medical Clinical Research Center of Medical Center LLC Health Clinic

    Vinnytsia,
    Ukraine

    Site Not Available

  • Vinnytsia Regional Clinical Hospital Hospital n.a. M.I. Pyrohov

    Vinnytsia,
    Ukraine

    Site Not Available

  • Small Business Private Enterprise Medical Center "Pulse"

    Vinnytsya,
    Ukraine

    Site Not Available

  • Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council

    Zaporizhzhia,
    Ukraine

    Site Not Available

  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

    Zaporizhzhia,
    Ukraine

    Site Not Available

  • Medical Centre of PE First Private Clinic

    Zhytomyr,
    Ukraine

    Site Not Available

  • Adobe Clinical Research, LLC

    Tucson, Arizona
    United States

    Site Not Available

  • Preferred Research Partners

    Little Rock, Arkansas
    United States

    Site Not Available

  • WCCT Global, LLC

    Costa Mesa, California
    United States

    Site Not Available

  • United Research Institute

    Murrieta, California
    United States

    Site Not Available

  • Gastroenterology Consultants of Clearwater

    Clearwater, Florida
    United States

    Site Not Available

  • Research Associates of South Florida, LLC

    Miami, Florida
    United States

    Site Not Available

  • IMIC

    Palmetto Bay, Florida
    United States

    Site Not Available

  • Medical Research Center of Florida

    Pembroke Pines, Florida
    United States

    Site Not Available

  • Clinical Research Center of Florida

    Pompano Beach, Florida
    United States

    Site Not Available

  • Lenus Research and Medical Group

    Sweetwater, Florida
    United States

    Site Not Available

  • Investigational site

    Winter Park, Florida
    United States

    Site Not Available

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana
    United States

    Site Not Available

  • MGG Group Co., Inc., Chevy Chase Clinical Research

    Chevy Chase, Maryland
    United States

    Site Not Available

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan
    United States

    Site Not Available

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina
    United States

    Site Not Available

  • Wilmington Gastroenterology Associates

    Wilmington, North Carolina
    United States

    Site Not Available

  • Great Lakes Gastroenterology Research

    Mentor, Ohio
    United States

    Site Not Available

  • Associates in Gastroenterology, PLC

    Hermitage, Tennessee
    United States

    Site Not Available

  • Quality Medical Research, PLLC

    Nashville, Tennessee
    United States

    Site Not Available

  • BI Research Center

    Houston, Texas
    United States

    Site Not Available

  • Biopharma Informatic Inc.

    Houston, Texas
    United States

    Site Not Available

  • Digestive Health Center

    Pasadena, Texas
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas
    United States

    Site Not Available

  • Advanced Research Institute

    Ogden, Utah
    United States

    Site Not Available

  • New River Valley Research Institute

    Christiansburg, Virginia
    United States

    Site Not Available

  • Digestive & Liver Disease Specialists

    Norfolk, Virginia
    United States

    Site Not Available

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