Overview

This trial is active, not recruiting.

Condition collagenous colitis
Treatments budesonide, sigmoidoscopy
Phase phase 3
Sponsor Bonderup, Ole K., M.D.
Collaborator AstraZeneca
Start date September 2004
End date March 2006
Trial size 36 participants
Trial identifier NCT00139165, okbon123

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Clinical symptoms
time frame:

Secondary Outcomes

Measure
Histological changes
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histological criteria of Collagenous colitis - Clinical activity (> 3 stools/day) Exclusion Criteria: - Treatment of Collagenous colitis within the last 3 months

Additional Information

Official title Long-Term Treatment of Collagenous Colitis With Budesonide. Prospective, Doubleblind Placebo-Controlled Trial.
Principal investigator Ole K Bonderup, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by Bonderup, Ole K., M.D..