Long-Term Treatment of Collagenous Colitis With Budesonide
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...
Brief Summary
Official Title: “Long-Term Treatment of Collagenous Colitis With Budesonide. Prospective, Doubleblind Placebo-Controlled Trial.”
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)
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Budesonide
- Capsule. Oral 6 mg o.d. for 24 weeks
- Procedure: sigmoidoscopy
- Sigmoidoscopy performed 2 times during the study period.
Outcome Measures for this Clinical Trial
Primary Measures
- Clinical symptoms
Secondary Measures
- Histological changes
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Histological criteria of Collagenous colitis
- Clinical activity (> 3 stools/day)
Exclusion Criteria:
- Treatment of Collagenous colitis within the last 3 months
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Bonderup, Ole K., M.D. Other
Overall Clinical Trial Officials and Contacts
Ole K Bonderup, MD Principal Investigator
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139165
Study ID Number: okbon123
ClinicalTrials.gov Identifier: NCT00139165
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00139165
