NCT00554099

Asacol Acute Diverticulitis(DIVA)Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed to evaluate the safety and efficacy of Asacol® 2.4 g/day in generally healthy, adult patients who have had an attack of acute diverticulitis. The study will evaluate the safety and efficacy of a 12 week treatment with Asacol® followed a 9 month non-treatment observation period in approximately 180 patients with acute diverticulitis.

Conditions

• Diverticulitis

Interventions

Type	Name	Description
DRUG	Mesalamine	6 - 400 mg tablets once daily
DRUG	Probiotic	Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
DRUG	Placebo	6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.
OTHER	Dietary Advice	Dietary advice
DRUG	Antibiotic for Diverticulitis	Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-11-06
• Last updated: 2013-04-22
• Results posted: 2011-06-21

Locations

36 sites across 1 country: United States