Long-Term Treatment of Collagenous Colitis With Budesonide

Phase 3

• Conditions: Collagenous Colitis

• Registration Number: NCT00139165
• Lead Sponsor: Bonderup, Ole K., M.D.

Brief Summary

The aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms (number of daily stools)

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Status Verified: 2005-08
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-31
• Study Completion: 2006-03
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Histological criteria of Collagenous colitis
• Clinical activity (> 3 stools/day)

Read More

Exclusion Criteria

• Treatment of Collagenous colitis within the last 3 months

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical symptoms

Secondary Outcome Measures

Name	Time	Method
Histological changes

Trial Locations

Locations (1)

Dept. of medical gastroenterology; 🇩🇰 Aarhus, Denmark