Budesonide for Maintenance Treatment of Collagenous Colitis
Phase 3
Completed
- Conditions
- Collagenous Colitis
- Registration Number
- NCT00180076
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.
- Detailed Description
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
- collagenous colitis
- diarrhea
- written informed consent
Exclusion Criteria
- infectious causes for diarrhea
- other inflammatory bowel diseases
- history of colonic surgery
- celiac disease
- malignancies
- severe concomitant diseases
- use of budesonide, steroids, mesalazine within the previous 2 weeks
- known intolerance to budesonide
- history of lack of response to budesonide
- pregnancy,lactation
- drug and/or alcohol abuse
- lack of compliance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of patients in clinical remission after 6 months
- Secondary Outcome Measures
Name Time Method time to relapse safety quality of life histological improvement
Trial Locations
- Locations (1)
Medical Department I, Technical University Hospital
🇩🇪Dresden, Germany