Budesonide for Maintenance Treatment of Collagenous Colitis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

November 17, 2009

Start Date ^ICMJE

July 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Proportion of patients in clinical remission after 6 months

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00180076 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

time to relapse
safety
quality of life
histological improvement

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Budesonide for Maintenance Treatment of Collagenous Colitis

Official Title ^ICMJE

Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis

Brief Summary

The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Detailed Description

The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Collagenous Colitis

Intervention ^ICMJE

Drug: Budesonide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Stephan Miehlke, Prof.	+49 351 458 ext 5645	stephan.miehlke@uniklinikum-dresden.de
Contact: Ahmed Madisch, MD	+49 351 458 ext 4780	ahmed.madisch@uniklinikum-dresden.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00180076

Responsible Party

Study ID Numbers ^ICMJE

MIMIC

Study Sponsor ^ICMJE

Dresden University of Technology

Collaborators ^ICMJE

AstraZeneca

Investigators ^ICMJE

Principal Investigator:

Stephan Miehlke, Prof.

Medical Department I, Technical University Hospital, Dresden, Germany

Information Provided By

Dresden University of Technology

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP