At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 228 enrolled
Drug / intervention
Mesalamine +1 moredrug
Likely dose
Not stated in 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, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Mesalamine and Placebo for Ulcerative Colitis. Completed, enrolled 228 participants across 93 sites in 11 countries.
Detailed Summary
The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesBulgaria, Canada, Hungary, Latvia, Mexico, Poland, Russia, Serbia, Switzerland, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartOct 2015
Primary CompletionFeb 2018
Study CompletionApr 2018
TodayJul 2026
First PostedAug 13, 2015
Enrollment StartOct 1, 2015
Primary CompletionFeb 6, 2018
Study CompletionApr 3, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.9 years ago
Interventions
Mesalaminedrug
Placebodrug