At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 117 enrolled
Drug / intervention
Mesalamine +4 moredrug
Likely dose
Mesalamine 400 mgfrom 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 Study to Assess the Safety and Efficacy of a 12 Week Treatment of Acute Diverticulitis With Asacol® 2.4 g/Day (400 mg Mesalamine Tablet), Followed by a 9 Month Treatment-free Observation Period
In Brief
A Phase 2 clinical trial evaluating Mesalamine, Probiotic, and 3 other interventions for Diverticulitis. Completed, enrolled 117 participants across 36 sites.
Detailed Summary
The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiverticulitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedNov 2007
Primary CompletionMar 2010
TodayJul 2026
First PostedNov 6, 2007
Enrollment StartNov 1, 2007
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.7 years ago
Interventions
Mesalaminedrug
6 - 400 mg tablets once daily
Probioticdrug
Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
Placebodrug
6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.
Dietary Adviceother
Dietary advice
Antibiotic for Diverticulitisdrug
Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.