Active, not recruiting

Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects with Mild to Moderate Ulcerative Colitis

This study is no longer recruiting. Please check back for study results.

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WHAT IS THE PURPOSE OF THIS STUDY?

To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.

TRIAL AT A GLANCE

Condition

Ulcerative Colitis

Study Intervention

MMX Mesalamine/Mesalazine (Low Dose); MMX Mesalamine/Mesalazine (High Dose)

Possibility of Active Treatment

100%

Study Type

Interventional

Phase

Phase 3

IS THIS STUDY RIGHT FOR ME?

AGE

5 to 17

Years

GENDERS

ACCEPTS HEALTHY VOLUNTEERS

No

PARTICIPATION DURATION/ REQUIREMENTS

Study participation will last approximately 8 weeks (6 visits) for the treatment phase and 26 weeks (8 visits) for the maintenance phase, and includes1 follow up phone call.

ENTRY CRITERIA

Confirmed diagnoses of mild to moderate ulcerative colitis

Weighs between 18-90kg (39-198 lbs)

Able to swallow pills

No severe ulcerative colitis, Crohn’s disease, bleeding disorders, or active peptic ulcer disease

No previous use of biologic drugs

Study Locations

    • Canada
    • Hungary
    • Israel
    • Poland
    • Slovakia
    • United Kingdom
    • United States of America

Enter your city or postal code to find a location near you.

RESULTS

  • 1.

    University of Minnesota Children's Hospital

    Minneapolis, MN
    United States of America

    miles

  • 2.

    Columbia University Medical Center

    New York, NY
    United States of America

    miles

  • 3.

    UT Southwestern Medical Center

    Dallas, TX
    United States of America

    miles

  • 4.

    SUNY at Buffalo

    Buffalo, NY
    United States of America

    miles

  • 5.

    Ann & Robert H. Lurie Children's Hospital

    Chicago, IL
    United States of America

    miles

  • 6.

    Penn State Milton S. Hershey Medical Center

    Hershey, PA
    United States of America

    miles

  • 7.

    University of Alberta Pediatric Gastroenterology & Nutrition

    Edmonton, Alberta
    Canada

    miles

  • 8.

    Samodzielny Publiczny Dzieciercy Szpital Kliniczny

    Warszawa,
    Poland

    miles

  • 9.

    Alder Hey Children's Hospital

    Liverpool,
    United Kingdom

    miles

  • 10.

    King's College Hospital

    London,
    United Kingdom

    miles

  • 11.

    BAZ MEGYEI KORHAZ ES EGYETEMI OKTATOKORHAZ

    Miskolc,
    Hungary

    miles

  • 12.

    SEMMELWEIS UNIVERSITY

    Budapest,
    Hungary

    miles

  • 13.

    UZ BRUSSEL CHILDREN HOSPITAL

    Brussels,
    Belgium

    miles

  • 14.

    UNIVERSITATS KINDERKLINIK ESSEN KINDERKLINIK II

    Essen,
    Germany

    miles

  • 15.

    UNIWERSYTECKI SZPITAL KLINICZNY WE WROCŁAWIU

    Wrocław,
    Poland

    miles

  • 16.

    Isala Ziekenhuis - Amalia Kindercentrum

    Zwolle,
    Netherlands

    miles

  • 17.

    Shaare Zedek Medical Center

    Jerusalem,
    Israel

    miles

  • 18.

    Emma Kinderziekenhuis AMC

    Amsterdam,
    Netherlands

    miles

  • 19.

    Arnold Palmer Hospital for Children

    Orlando, FL
    United States of America

    miles

  • 20.

    ERASMUS MC Sophia Children's Hospital

    Rotterdam,
    Netherlands

    miles

  • 21.

    Szent Janos Korhaz És Észak-budai Egyesitett Korha

    Budapest,
    Hungary

    miles

  • 22.

    John Hopkins

    Baltimore, MD
    United States of America

    miles

  • 23.

    Klinika Pediatrii Gastroenterologii I Zywienia

    Krakow,
    Poland

    miles

  • 24.

    Univerzitna Nemocnica Martin

    Martin,
    Slovakia

    miles

  • 25.

    Bekes Megyei Pandy Kalman Korhaz

    Gyula,
    Hungary

    miles

  • 26.

    Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhaz

    Nyiregyhaza,
    Hungary

    miles

  • 27.

    University of Maryland Children's Hospital

    Baltimore, MD
    United States of America

    miles

  • 28.

    Soroka Medical Center

    Be'er Sheva, Israel
    Israel

    miles

  • 29.

    Radboud UMC

    Nijmegen,
    Netherlands

    miles

  • 30.

    Detská fakultná nemocnica s poliklinikou

    Banska Bystrica,
    Slovakia

    miles

  • 31.

    Wojewodzki Specjalistyczny Szpital Dzieciecy

    Olsztyn,
    Poland

    miles

  • 32.

    Oddzial Gastroenterologii I Hepatologii

    Warszawa,
    Poland

    miles

  • 33.

    Rambam Health Corporation

    Haifa, Israel
    Israel

    miles

  • 34.

    Great Ormond Street Hospital

    London,
    United Kingdom

    miles

  • 35.

    Klinika Gastroenterologii I Pediatrii

    Lodz,
    Poland

    miles

  • 36.

    Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Korányi, Szeged
    Hungary

    miles

  • 37.

    Texas Digestive Disease Consultants

    Southlake, TX
    United States of America

    miles

  • 38.

    Carilion Medical Center

    Roanoke, Virginia
    United States of America

    miles

  • 39.

    Massachusetts General Hospital

    Boston, MA
    United States of America

    miles

  • 40.

    IWK Health Centre

    Halifax, Nova Scotia
    Canada

    miles

  • 41.

    Gabinet Lekarski-Bartosz Korczowski

    Rzeszow,
    Poland

    miles

  • 42.

    Mayo Clinic Gastroenterology

    Rochester, MN
    United States of America

    miles

  • 43.

    Barts Health NHS Trust, Royal London Hospital

    London,
    United Kingdom

    miles

  • 44.

    Copernicus Podmiot Leczniczy sp. z o.o

    Gdansk,
    Poland

    miles

  • 45.

    Schneider Medical Centre

    Petach Tikva, Israel
    Israel

    miles

  • 46.

    Uniwersytecki Dzieciecy Szpital Kliniczny im. Ludwika Zamenhofa

    Bialystok,
    Poland

    miles

  • 47.

    University Children's Hospital

    Bratislava,
    Slovakia

    miles

  • 48.

    Newton Wellesley Hospital

    Newton, MA
    United States of America

    miles