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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double-blind, Randomised, Placebo-controlled, Parallel-group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Pellets vs. Placebo in Divertic

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 Summary:
Sponsor: Dr. Falk Pharma GmbH

Current Primary Outcome: The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28) [ Time Frame: 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


Original Primary Outcome: Change in intensity of lower abdominal pain during the first four weeks of treatment [ Time Frame: 4 weeks ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Dr. Falk Pharma GmbH

Dates:
Date Received: June 21, 2012
Date Started: May 2002
Date Completion:
Last Updated: January 20, 2016
Last Verified: January 2016