Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study

Phase 2

Completed

• Conditions: Colonic Diverticulosis
• Interventions: Drug: Placebo; Drug: Mesalamine

• Registration Number: NCT01627262
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

The purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2004-08
• Study Completion: 2006-04
• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-25
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Diagnosis of diverticular disease with acute pain without serious complications
• Lower abdominal pain of moderate or severe intensity at least during the last 4 days before study inclusion

Exclusion Criteria

• Chronic inflammatory bowel disease
• Fever or other signs of serious complications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Mesalamine	Mesalamine	-

Primary Outcome Measures

Name	Time	Method
The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28)	4 weeks	The change in intensity of lower abdominal pain during the first four weeks of treatment, defined as the cumulative difference of the daily pain intensity score from the first day of study medication intake (day 1) to week 4

Trial Locations

Locations (1)

Ev. Krankenhaus Kalk, University of Cologne; 🇩🇪 Köln, Germany