At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 187 enrolled
Drug / intervention
Mesalazine +1 moredrug
Likely dose
Mesalazine 800mgfrom 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 Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.
In Brief
A Phase 3 clinical trial evaluating Mesalazine and Placebo for Irritable Bowel Syndrome. Completed, enrolled 187 participants across 22 sites.
Detailed Summary
The purpose of this study is to determine whether Mesalazine is effective in the treatment of the abdominal discomfort or pain of Irritable Bowel Syndrome patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedFeb 2008
Primary CompletionMar 2012
Study CompletionJul 2012
TodayJul 2026
First PostedFeb 29, 2008
Enrollment StartDec 1, 2007
Primary CompletionMar 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.3 years ago
Interventions
Mesalazinedrug
Mesalazine 800mg t.i.d. 12 weeks
Placebodrug
Placebo cpr, t.i.d. 12 weeks