Now Recruiting

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

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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

We are planning* on conducting this study in 8 countries around the world.

    • Canada
    • Hungary
    • Israel
    • Netherlands
    • 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

    212-305-6274

    er2564@columbia.edu

    miles

  • 3.

    UT Southwestern Medical Center

    Dallas, TX
    United States of America

    214-456-9238

    takiyah.wilson@childrens.com

    miles

  • 4.

    SUNY at Buffalo

    Buffalo, NY
    United States of America

    716-878-7391

    sowilliams@upa.chob.edu

    miles

  • 5.

    Ann & Robert H. Lurie Children's Hospital

    Chicago, IL
    United States of America

    krjohnson@luriechildrens.org

    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

    1-780-248-5610

    faye.murdoch@albertahealthservices.ca

    miles

  • 8.

    Samodzielny Publiczny Dzieciercy Szpital Kliniczny

    Warszawa,
    Poland

    +48 501 701 265

    lukaszdembinski@gmail.com

    miles

  • 9.

    Alder Hey Children's Hospital

    Liverpool,
    United Kingdom

    +44 0151 228 4811

    theresa.moorcroft@alderhey.nhs.uk

    miles

  • 10.

    King's College Hospital

    London,
    United Kingdom

    +44-02-0-3299 2129

    holly.dickson@nhs.net

    miles

  • 11.

    Samodzielny Publiczny Szpital Kliniczny N 1

    Wrocław,
    Poland

    +48 664 722 160

    vermer20@poczta.onet.pl

    miles

  • 12.

    Isala Ziekenhuis - Amalia Kindercentrum

    Zwolle,
    Netherlands

    +31 38 424 8138

    researchkindergenees@isala.nl

    miles

  • 13.

    Shaare Zedek Medical Center

    Jerusalem,
    Israel

    972-2-5645028

    tahilabm@szmc.org.il

    miles

  • 14.

    Emma Kinderziekenhuis AMC

    Amsterdam,
    Netherlands

    +31 20 566 8000

    f.k.khawaja@amc.nl

    miles

  • 15.

    Arnold Palmer Hospital for Children

    Orlando, FL
    United States of America

    407-786-9715

    Linda.Tilme@orlandohealth.com

    miles

  • 16.

    ERASMUS MC Sophia Children's Hospital

    Rotterdam,
    Netherlands

    miles

  • 17.

    Szent Janos Korhaz És Észak-budai Egyesitett Korha

    Budapest,
    Hungary

    +36 30 633 7944

    veleszova@vipmail.hu

    miles

  • 18.

    John Hopkins

    Baltimore, MD
    United States of America

    410-955-6801

    nmoore22@jhmi.edu

    miles

  • 19.

    Klinika Pediatrii Gastroenterologii I Zywienia

    Krakow,
    Poland

    +48 126574012

    sikorka4@o2.pl

    miles

  • 20.

    Univerzitna Nemocnica Martin

    Martin,
    Slovakia

    miles

  • 21.

    Bekes Megyei Pandy Kalman Korhaz

    Gyula,
    Hungary

    +36 20 265 0065

    kolani@freemail.hu 

    miles

  • 22.

    Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhaz

    Nyiregyhaza,
    Hungary

    +36 30 535 5868

    dnagyrita@hotmail.com

    miles

  • 23.

    University of Maryland Children's Hospital

    Baltimore, MD
    United States of America

    miles

  • 24.

    Soroka Medical Center

    Be'er Sheva, Israel
    Israel

    972-8-6244245

    maka@bgu.ac.il

    miles

  • 25.

    Radboud UMC

    Nijmegen,
    Netherlands

    +31243615035

    j.gilissen@cukz.umcn.nl

    miles

  • 26.

    Detská fakultná nemocnica s poliklinikou

    Banska Bystrica,
    Slovakia

    miles

  • 27.

    Wojewodzki Specjalistyczny Szpital Dzieciecy

    Olsztyn,
    Poland

    +48 895393462

    adauk@mp.pl

    miles

  • 28.

    Oddzial Gastroenterologii I Hepatologii

    Warszawa,
    Poland

    + 48508102296

    gosiam86@gmail.com

    miles

  • 29.

    Rambam Health Corporation

    Haifa, Israel
    Israel

    972-50-2063813

    a_ronai@rambam.health.gov.il

    miles

  • 30.

    Great Ormond Street Hospital

    London,
    United Kingdom

    +44 0207 405 9200

    heather.godwin@gosh.nhs.uk

    miles

  • 31.

    Klinika Gastroenterologii I Pediatrii

    Lodz,
    Poland

    +48-42-271-13-49

    beatasordyl@op.pl

    miles

  • 32.

    Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Korányi, Szeged
    Hungary

    +36 20 216 7767

    rozsapetra@hotmail.com

    miles

  • 33.

    Texas Digestive Disease Consultants

    Southlake, TX
    United States of America

    817-310-4489

    AFalcon@tddctx.com

    miles

  • 34.

    Carilion Medical Center

    Roanoke, Virginia
    United States of America

    540-224.6751

    cmflorow@carilionclinic.org

    miles

  • 35.

    Massachusetts General Hospital

    Boston, MA
    United States of America

    781-727-7729

    ekochergin@mgh.harvard.edu

    miles

  • 36.

    IWK Health Centre

    Halifax, Nova Scotia
    Canada

    +1 902-470-7009

    Brad.MacIntyre@iwk.nshealth.ca

    miles

  • 37.

    Gabinet Lekarski-Bartosz Korczowski

    Rzeszow,
    Poland

    +48 (17)8664141

    anna-grad@wp.pl

    miles

  • 38.

    Mayo Clinic Gastroenterology

    Rochester, MN
    United States of America

    507-266-9917

    Boe.Gwen@mayo.edu

    miles

  • 39.

    Barts Health NHS Trust, Royal London Hospital

    London,
    United Kingdom

    +44 020-359-41455

    Hilarious.DeJesus@bartshealth.nhs.uk

    miles

  • 40.

    Copernicus Podmiot Leczniczy sp. z o.o

    Gdansk,
    Poland

    48 587640239

    wradys@gumed.edu.pl

    miles

  • 41.

    Schneider Medical Centre

    Petach Tikva, Israel
    Israel

    972-3-9253376

    reutkl@clalit.org.il

    miles

  • 42.

    Uniwersytecki Dzieciecy Szpital Kliniczny im. Ludwika Zamenhofa

    Bialystok,
    Poland

    +48857450706

    mirusc@o2.pl

    miles

  • 43.

    University Children's Hospital

    Bratislava,
    Slovakia

    +421 902106179

    katarina.hlavata@yahoo.com

    miles

  • 44.

    Newton Wellesley Hospital

    Newton, MA
    United States of America

    617-243-5855

    MAWASHEK@mgh.harvard.edu

    miles

*Planning is an intent to conduct this study in the specified countries and is subject to change.