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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

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

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