Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

Last updated: January 26, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Completed

Phase

3

Condition

Pain (Pediatric)

Pain

Treatment

N/A

Clinical Study ID

NCT01270828
A0081224
2009-016766-86
  • Ages > 18
  • All Genders

Study Summary

The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have pain present for more than 3 months after the healing of the herpeszoster skin rash.
  • At screening (V1) and enrollment (V2), patients must have a score of greater than orequal to 4 on the Pain Numeric Rating Scale (1 week recall period).
  • At enrollment (V2), at least 4 pain diaries must be completed satisfactorily withinthe last 7 days and the average pain score must be greater than or equal to 4.
  • Male or female of any race, at least 18 years of age, and using appropriate methods ofcontraception

Exclusion

Exclusion Criteria:

  • Creatinine clearance <30 mL/min (estimated from serum creatinine).
  • Skin conditions in the affected dermatome that could alter sensation
  • Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 daysshould be washed out of pregabalin for at least 30 days prior to screening visit.Patients who had not responded to pregabalin

Study Design

Total Participants: 806
Study Start date:
March 01, 2011
Estimated Completion Date:
November 30, 2014

Connect with a study center

  • DCC "St. Pantaleimon" OOD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • MHAT-Pleven

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Mnogoprofilna bolnitsa za aktivno lechenie Shumen

    Shumen, 9700
    Bulgaria

    Site Not Available

  • MBAL "Tokuda Bolnitsa", Otdelenie po nevrologiya

    Sofia, 1407
    Bulgaria

    Site Not Available

  • MBALNP "Sveti Naum" EAD, Klinika po nervni bolesti za dvigatelni narushenia

    Sofia, 1113
    Bulgaria

    Site Not Available

  • Universitetska mnogoprofilna bolnitsa za aktivno lechenie Aleksandrovska, Klinika po Nevrologia

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie ¿ Sofia, AD, Sofia, Nevrologichno otdelenie

    Sofia, 1202
    Bulgaria

    Site Not Available

  • Reumalab S.A.S

    Medellin, Antioquia
    Colombia

    Site Not Available

  • Centro de Investigacion y Atencion Para la Salud Mental S.A. - CESAME

    Bogota, Cundinamarca 0
    Colombia

    Site Not Available

  • Fundacion Cardiovascular de Colombia

    Floridablanca, Santander 0
    Colombia

    Site Not Available

  • Opca bolnica Karlovac

    Karlovac, Karlovacka Županija 47000
    Croatia

    Site Not Available

  • Klinicki Bolnicki Centar Osijek

    Osijek, Osjecko-baranjska Županija 31000
    Croatia

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  • Opca bolnica "Dr. Ivo Pedisic"

    Sisak, Sisacko-moslavacka Županija 44000
    Croatia

    Site Not Available

  • Fakultni necmocnice u sv. Anny v Brne

    Brno, 656 91
    Czech Republic

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  • Neurologicka ambulance

    Ostrava - Hrabuvka, 70030
    Czech Republic

    Site Not Available

  • Fakultni nemocnice Plzen

    Plzen, 304 60
    Czech Republic

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  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 12800
    Czech Republic

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  • Fakultni nemocnice v Motole

    Praha 5, 150 06
    Czech Republic

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  • Neurologicka ambulance

    Prerov I, 750 02
    Czechia

    Site Not Available

  • Aalborg Sygehus Nord

    Aalborg, Region Nordjylland DK-900
    Denmark

    Site Not Available

  • Glostrup Hospital

    Glostrup, DK-2066
    Denmark

    Site Not Available

  • Praxis (Weiss)

    Mannheim, Baden-Württemberg 68161
    Germany

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  • Schmerzzentrum Frankfurt

    Frankfurt/Main, Hessen 60311
    Germany

    Site Not Available

  • Schmerzzentrum Celle

    Celle, Niedersachsen 29221
    Germany

    Site Not Available

  • pro scientia med im MARE Klinikum

    Kiel-Kronshagen, Schleswig-Holstein 24119
    Germany

    Site Not Available

  • DGS-Schmerzzentrum Eichstätt

    Eichstaett, 85072
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Schmerz- und Psychotherapie

    Hamburg, 22767
    Germany

    Site Not Available

  • Schmerztherapiezentrum VS

    Villingen-Schwenningen, 78054
    Germany

    Site Not Available

  • Family Medicine

    Hong Kong,
    Hong Kong

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  • Queen Elizabeth Hospital

    Kowloon,
    Hong Kong

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  • The Chinese University of Hong Kong, Department of Anaesthesia and Intensive Care

    New Territories, 0
    Hong Kong

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  • Medanta Institute of Neurosciences

    Gurgaon, Haryana 122 001
    India

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  • M. S. Ramaiah Medical College and Hospitals

    Bangalore, Karnataka 560 054
    India

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    Bangalore, Karnataka 560 017
    India

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  • Mallikatta Neuro Centre

    Mangalore, Karnataka 575002
    India

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  • Indraprastha Apollo Hospitals

    New Delhi, 110 076
    India

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  • "SYNEXUS POLSKA" Sp. z o.o.

    Wroclaw, Dolnoslaskie 50088
    Poland

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  • Prof. dr hab. med. Leszek Szepanski Prywatna Praktyka Lekarska Gabinet Reumatologiczny

    Lublin, Lubelskie 20022
    Poland

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  • "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Warszawie

    Warszawa, Mazowieckie 01192
    Poland

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  • Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z o.o.

    Gdansk, Pomorskie 80286
    Poland

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    Gdynia, Pomorskie 81384
    Poland

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    Katowice, Slaskie 40040
    Poland

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  • Maopolskie Centrum Medyczne s.c.

    Krakow, 30-510
    Poland

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  • Caribbean Clinical Trials, Corporation

    San Juan, 00927
    Puerto Rico

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  • Kazan State Medical University

    Kazan, Tatarstan, Respublika 420064
    Russian Federation

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  • State Budgetary Educational Institution for higher Professional Training "Kazan State Medical Univer

    Kazan, Tatarstan, Respublika 119992
    Russian Federation

    Site Not Available

  • GBUZ Nizhny Novgorod Regional Clinical Hospital N.A. Semashko

    Nizhny Novgorod, 603126
    Russian Federation

    Site Not Available

  • Clinic of Nervous Diseases M.I. Astvatsaturov

    Saint-Petersburg, 194175
    Russian Federation

    Site Not Available

  • St. Petersburg State Healthcare Institution City Hospital # 40 Kurortnogo Administrativnogo Rajona

    Saint-Petersburg, 197706
    Russian Federation

    Site Not Available

  • State Budgetary Educational Institution for Higher Professional Education

    Smolensk, 214019
    Russian Federation

    Site Not Available

  • State Budgetary Health Institution of Yaroslavl region "Clinical hospital #10"

    Yaroslavl, 150023
    Russian Federation

    Site Not Available

  • Clinic for Neurology

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinic for neurology, Clinical centre Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Clinic for Neurology

    Nis, 18000
    Serbia

    Site Not Available

  • Changi General Hospital

    Singapore, 529889
    Singapore

    Site Not Available

  • Euro-Neuro s.r.o., Neurologicka ambulancia

    Bratislava, 831 03
    Slovakia

    Site Not Available

  • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Neurologicke oddelenie

    Bratislava, 851 07
    Slovakia

    Site Not Available

  • MUDr. Eva Gasparova - neurologicka ambulancia

    Hlohovec, 920 01
    Slovakia

    Site Not Available

  • Univerzitna nemocnica L. Pasteura Kosice

    Kosice, 040 11
    Slovakia

    Site Not Available

  • Neurologicka ambulancia, Neuron-DT,s.r.o.

    Zilina, 01001
    Slovakia

    Site Not Available

  • Border Diabetic Centre

    East London, Eastern Cape 5200
    South Africa

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  • Nelson Mandela Academic Hospital Research Unit

    Mthatha, Eastern Cape 5099
    South Africa

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  • Iatros International

    Bloemfontein, 9301
    South Africa

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  • Synapta Clinical Research Centre

    Durban, 4001
    South Africa

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  • Mzansi Ethical Research Centre

    Middelburg, 1050
    South Africa

    Site Not Available

  • Jakaranda Pain Clinic

    Pretoria, 0014
    South Africa

    Site Not Available

  • Probare

    Lund, Skane Lan 222 22
    Sweden

    Site Not Available

  • CTC, Sahlgrenska sjukhuset/SU

    Goteborg, 413 45
    Sweden

    Site Not Available

  • Me3plus Clinical Trials

    Goteborg, 412 63
    Sweden

    Site Not Available

  • Center for Lakemedelsstudier

    Malmo, 211 52
    Sweden

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  • Bragee Medect AB

    Stockholm, 115 22
    Sweden

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  • Chang Gung Medical Foundation-Linkou Branch

    Kwei Shan Town, Taoyuan County 333
    Taiwan

    Site Not Available

  • Chang-Hua Christian Hospital

    Changhua, 500
    Taiwan

    Site Not Available

  • National Taiwan University Hospital (Neurology)

    Taipei, 100
    Taiwan

    Site Not Available

  • Public Institution "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine"

    Kharkiv, 61068
    Ukraine

    Site Not Available

  • Kyiv City Clinical Hospital #4

    Kyiv, 03110
    Ukraine

    Site Not Available

  • Lviv NMU n.a. Danylo Galytskyy

    Lviv, 79013
    Ukraine

    Site Not Available

  • Regional Municipal Dermatovenerologic Dispensary

    Lviv, 79013
    Ukraine

    Site Not Available

  • Crimean Republican Institution "Clinical Dermatovenerologic Dispensary"

    Simferopol, 95006
    Ukraine

    Site Not Available

  • Municipal Institution of Ternopil Regional Council "Ternopil University Hospital"

    Ternopil, 46000
    Ukraine

    Site Not Available

  • Municipal Establishment "Vinnitsa Regional Psychoneurological Hospital n.a. O.I. Yushchenko"

    Vinnitsa, 21005
    Ukraine

    Site Not Available

  • Municipal Establishment "City Clinical Hospital #2", Neurology Department

    Zaporizhzhya, 69068
    Ukraine

    Site Not Available

  • Fundamental Research

    Gulf Shores, Alabama 36542
    United States

    Site Not Available

  • Physicians Pain Specialists of Alabama, PC

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Radiant Research, Inc.

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Elite Clinical Studies, LLC

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • HOPE Research Institute

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • The Pain Center of Arizona

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Genova Clinical Research

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Hearne Family Practice Clinic

    Little Rock, Arkansas 72206
    United States

    Site Not Available

  • Larry Watkins, M.D. (Private Practice)

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas 72205
    United States

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  • Advanced Pain Research Institute

    Arcadia, California 91007
    United States

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  • Center for Clinical Research, Inc

    Carmichael, California 95608
    United States

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  • Community Medical Providers

    Clovis, California 93611
    United States

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  • Sierra Medical Research

    Clovis, California 93612
    United States

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  • Inland Pain Medicine

    Colton, California 92324
    United States

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  • Sierra Medical Research

    Fresno, California 93710
    United States

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  • The Helm Center

    Laguna Hills, California 92637
    United States

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  • USC IDS Pharmacy

    Los Angeles, California 90089
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

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  • Translational Research Group, Inc

    North Hollywood, California 91606
    United States

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  • George J. Rederich, M.D., Incorporated

    Redondo Beach, California 90277
    United States

    Site Not Available

  • Integrated Research Group, Inc.

    Riverside, California 92506
    United States

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  • Drug Shipmnent Only Aristotelis T. Laliotis, M.D. Integrated Research Center, Inc.

    San Diego, California 92117
    United States

    Site Not Available

  • Integrated Research Center, Inc.

    San Diego, California 92117
    United States

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  • Center For Clinical Research, Inc.

    San Francisco, California 94115
    United States

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  • Neurological Research Institute

    Santa Monica, California 90404
    United States

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  • Foothills Pain Management Clinic, PS

    West Covina, California 91790
    United States

    Site Not Available

  • JEM Research Institute

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Orthopedic Research Institute

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Clinical Physiology Associates

    Fort Myers, Florida 33916
    United States

    Site Not Available

  • Health Care Family Rehab & Research Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Laszlo Jozsef Mate, MD

    North Palm Beach, Florida 33408
    United States

    Site Not Available

  • Family Care Specialists

    Ocala, Florida 34471
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34471
    United States

    Site Not Available

  • Compass Research, LLC

    Orlando, Florida 32806
    United States

    Site Not Available

  • Comprehensive Pain care of South Florida

    Royal Palm Beach, Florida 33411
    United States

    Site Not Available

  • Comprehensive Clinical Development Inc.

    Saint Petersburg, Florida 33716
    United States

    Site Not Available

  • Comprehensive Clinical Development Inc.

    St. Petersburg, Florida 33716
    United States

    Site Not Available

  • Neurology Clinical Research, Inc.

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Tampa, Florida 33603
    United States

    Site Not Available

  • Meridien Research

    Tampa, Florida 33606
    United States

    Site Not Available

  • Injury Care Medical Center

    Boise, Idaho 83713
    United States

    Site Not Available

  • Millennium Pain Center, LLC

    Bloomington, Illinois 61701
    United States

    Site Not Available

  • Chicago Anesthesia Associates

    Burr Ridge, Illinois 60527
    United States

    Site Not Available

  • (IP Shipping Address) Advocate Illinois Masonic Medical Center

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Chicago Anesthesia Pain Specialists

    Chicago, Illinois 60657
    United States

    Site Not Available

  • American Medical Research, Inc.

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • Chicago Anesthesia Associates

    Willowbrook, Illinois 60527
    United States

    Site Not Available

  • Advanced Pain Care Clinic

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Clinical Research Advantage

    Evansville, Indiana 47714
    United States

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  • Global Scientific Innovations

    Evansville, Indiana 47714
    United States

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  • Clinical Trials of America, Inc.

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Louisiana Research Associates, Inc.

    New Orleans, Louisiana 70114
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02135
    United States

    Site Not Available

  • Beacon Clinical Research

    Brockton, Massachusetts 02301
    United States

    Site Not Available

  • Infinity Medical Research, Inc.

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • QUEST Research Institute

    Bingham Farms, Michigan 48025
    United States

    Site Not Available

  • The Center for Pharmaceutical Research, PC

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Medex Healthcare Research, Inc.

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • Clinvest, A Division of Banyan Group, Inc

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Montana Medical Research Inc

    Missoula, Montana 59808
    United States

    Site Not Available

  • Lincoln Internal Medicine Associates

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Drug Shipment Only: Heartland Clinical Research, Inc.

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Heartland Clinical Research, Inc.

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • The Office of Dr. Stephen H. Miller, MD

    Las Vegas, Nevada 89144
    United States

    Site Not Available

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Dent Neurological Institute

    Amherst, New York 14226
    United States

    Site Not Available

  • SPRI Clinical Trials LLC

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Medex Healthcare Research, Inc - Saint Louis

    New York, New York 10036
    United States

    Site Not Available

  • North American Partners In Pain Management

    New York, New York 11580
    United States

    Site Not Available

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina 28806
    United States

    Site Not Available

  • Raleigh Neurology Associates, P.A.

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • The Center for Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Radiant Research

    Akron, Ohio 44311
    United States

    Site Not Available

  • Patient Priority Clinical Sites, LLC

    Cincinnati, Ohio 45215
    United States

    Site Not Available

  • Providence Health Partners-Center for Clinical Research

    Dayton, Ohio 45439
    United States

    Site Not Available

  • Wells Institute for Health Awareness

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Elise Wiesner, MD

    Norman, Oklahoma 73071
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Mark A Fisher

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Pain Research of Oregon, LLC

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Blair Medical Associates, Inc.

    Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • Drug Shipment Only

    Duncansville, Pennsylvania 16635-0909
    United States

    Site Not Available

  • Pharmacorp Clinical Trials, Inc.

    Charleston, South Carolina 29412
    United States

    Site Not Available

  • Arlington Research Center, Inc.

    Arlington, Texas 76011
    United States

    Site Not Available

  • Lovelace Scientific Resources, Inc.

    Austin, Texas 78758
    United States

    Site Not Available

  • Radiant Research

    Dallas, Texas 75231
    United States

    Site Not Available

  • ClinRx Research, LLC

    Richardson, Texas 75080
    United States

    Site Not Available

  • Hillcrest Family Health Centers, Division of Clinical Research

    Waco, Texas 76710
    United States

    Site Not Available

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin 53142
    United States

    Site Not Available

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