At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 281 enrolled
Drug / intervention
Mesalamindrug
Likely dose
Mesalamin 4.8gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Mesalamin for Ulcerative Colitis. Completed, enrolled 281 participants across 31 sites in 4 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesBelarus, India, Turkey (Türkiye), Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
First PostedJan 2010
Primary CompletionJul 2011
Study CompletionAug 2011
TodayJul 2026
First PostedJan 29, 2010
Enrollment StartNov 1, 2009
Primary CompletionJul 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.4 years ago
Interventions
Mesalamindrug
4.8g/day, 800 mg tablets