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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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.

Primary Measures

• Clinical symptoms

Secondary Measures

• Histological changes

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

Lead Sponsor: Bonderup, Ole K., M.D.

Overall Clinical Trial Officials and Contacts

Ole K Bonderup, MD Principal Investigator Unaffiliated  

Information obtained from ClinicalTrials.gov on July 02, 2009

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