NCT00450086

Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis

Double-blind, Double-dummy, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules vs. Mesalazine Granules vs. Placebo for Patients With Collagenous Colitis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.

Detailed description

This study will check the reproducibility of the results reported in trials with budesonide in patients with collagenous colitis. Efficacy of mesalazine was never tested in collagenous colitis by placebo-controlled trials. This trial will check the superiority of mesalazine over placebo using the common clinical symptom of collagenous colitis, which is chronic or recurrent non-bloody, watery diarrhea.

Conditions

• Collagenous Colitis

Interventions

Type	Name	Description
DRUG	Budesonide	9 mg per day
DRUG	Mesalazine	3 g per day
DRUG	Placebo	0 g per day

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-06-01
• Completion: 2011-08-01
• First posted: 2007-03-21
• Last updated: 2014-05-19

Locations

1 site across 1 country: Germany