Conditions: Ulcerative Colitis
Keywords: Mesalamine Asacol Ulcerative colitis induction therapy acute disease mild to moderate Active Ulcerative Colitis (mild to moderate)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 281
Healthy volunteers: no

Brief summary:
The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative colitis (UC).

Detailed description:
The 800 mg Asacol™ tablets from Tillotts Pharma AG are being marketed in over 30 countries, mainly in Europe and Asia. Approved dosages for the treatment of active UC are between 2.4 and 4.8 g/day in analogy to the approved 400 mg dosage form. The present trial is planned to generate efficacy data to support the safe use of a 4.8 g/day dose of the 800 mg dosage form in a well defined population of patients with mildly to moderately active UC. In keeping with the EMEA UC guideline the study will have a placebo-controlled 6 weeks induction treatment. After 6 weeks, treatment success will be evaluated using the modified UC disease activity index as primary efficacy measurement.

Arms:
arm 1: 4.8g Mesalamin (800mg tablet) arm 2: 4.8g Placebo to Mesalamin (800 mg tablet)

Interventions: intervention 1: Mesalamin
Intervention descriptions: intervention 1: 4.8g/day, 800 mg tablets

Protocol document: