Long-Term Treatment of Collagenous Colitis With Budesonide
Information source: Bonderup, Ole K., M.D.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Collagenous Colitis
Intervention: Budesonide (Drug); sigmoidoscopy (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Bonderup, Ole K., M.D. Official(s) and/or principal investigator(s):
Ole K Bonderup, MD, Principal Investigator, Affiliation: Unaffiliated
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)
Clinical Details
Official title: Long-Term Treatment of Collagenous Colitis With Budesonide. Prospective, Doubleblind Placebo-Controlled Trial.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Clinical symptoms
Secondary outcome: Histological changes
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Histological criteria of Collagenous colitis
- Clinical activity (> 3 stools/day)
Exclusion Criteria:
- Treatment of Collagenous colitis within the last 3 months
Locations and Contacts
Dept. of medical gastroenterology, Aalborg 9100, Denmark
Dept. of medical gastroenterology, Aarhus 8000, Denmark
Additional Information
Starting date: September 2004
Ending date: March 2006
Last updated: March 3, 2008
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