Status:
COMPLETED
Budesonide for Maintenance Treatment of Collagenous Colitis
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
AstraZeneca
Conditions:
Collagenous Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- collagenous colitis
- diarrhea
- written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00180076
Start Date
July 1 2004
End Date
March 1 2008
Last Update
March 30 2010
Active Locations (1)
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1
Medical Department I, Technical University Hospital
Dresden, Germany, 01307