Budesonide Treatment for Lymphocytic 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: Microscopic 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 the
treatment of lymphocytic colitis
Clinical Details
Official title: Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Proportion of patients in clinical remission after 6 weeks
Secondary outcome: safetyquality of life histological improvement
Detailed description:
The purpose of this study is to determine whether orale budesonide is effective in the
treatment of lymphocytic colitis
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- lymphocytic colitis
- diarrhea
- effective contraception
- written informed consent
Exclusion Criteria:
- other forms if IBD
- celiac disease
- infectious colitis
- history of colonic surgery
- use of budesonide, 5-ASA, steroids within th previous 4 weeks
- pregnancy, lactation
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: January 2002
Ending date: August 2005
Last updated: February 12, 2007
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