Budesonide for Maintenance Treatment of Collagenous Colitis
Information source: Dresden University of Technology
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Collagenous Colitis
Intervention: Budesonide (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Dresden University of Technology Official(s) and/or principal investigator(s):
Stephan Miehlke, Prof., Principal Investigator, Affiliation: Medical Department I, Technical University Hospital, Dresden, Germany
Overall contact:
Stephan Miehlke, Prof., Phone: +49 351 458, Ext: 5645, Email: stephan.miehlke@uniklinikum-dresden.de
Summary
The purpose of this study is to determine whether orale budesonide is effective in
maintaining clinical remission in patients with collagenous colitis.
Clinical Details
Official title: Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Proportion of patients in clinical remission after 6 months
Secondary outcome: time to relapsesafety quality of life histological improvement
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- collagenous colitis
- diarrhea
- written informed consent
Exclusion Criteria:
- 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
Locations and Contacts
Stephan Miehlke, Prof., Phone: +49 351 458, Ext: 5645, Email: stephan.miehlke@uniklinikum-dresden.de
Medical Department I, Technical University Hospital, Dresden 01307, Germany; Recruiting
Stephan Miehlke, Prof., Phone: +49 351 458, Ext: 5645, Email: stephan.miehlke@uniklinikum-dresden.de
Ahmed Madisch, MD, Phone: +49 351 458, Ext: 4780, Email: ahmed.madisch@uniklinikum-dresden.de
Stephan Miehlke, Prof., Principal Investigator
Additional Information
Starting date: July 2004
Ending date: August 2005
Last updated: February 12, 2007
|
