At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 276 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 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Mesalamine and Placebo for Ulcerative Colitis. Completed, enrolled 276 participants across 96 sites in 11 countries.
Detailed Summary
The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC. The duration of treatment for each subject was 6 months.
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 StartFeb 2016
Primary CompletionSep 2018
TodayJul 2026
First PostedAug 13, 2015
Enrollment StartFeb 1, 2016
Primary CompletionSep 19, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.9 years ago
Interventions
Mesalaminedrug
Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Placebodrug
Pharmaceutical form: Granules in sachet; Route of administration: Oral use