Budesonide for Maintenance Treatment of Collagenous Colitis

This study is currently recruiting participants.

Verified by Dresden University of Technology, August 2005

Sponsors and Collaborators:	Dresden University of Technology AstraZeneca
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00180076

Purpose

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

Condition	Intervention	Phase
Collagenous Colitis	Drug: Budesonide	Phase III

Drug Information available for: Budesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

Proportion of patients in clinical remission after 6 months

Secondary Outcome Measures:

time to relapse
safety
quality of life
histological improvement

Estimated Enrollment:	75
Study Start Date:	July 2004
Estimated Study Completion Date:	August 2005

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180076

Contacts

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

Locations

Germany
Medical Department I, Technical University Hospital	Recruiting
Dresden, Germany, 01307
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
Principal Investigator: Stephan Miehlke, Prof.

Sponsors and Collaborators

Dresden University of Technology

AstraZeneca

Investigators

Principal Investigator:

Stephan Miehlke, Prof.

Medical Department I, Technical University Hospital, Dresden, Germany

More Information

Study ID Numbers:	MIMIC
Study First Received:	September 9, 2005
Last Updated:	February 12, 2007
ClinicalTrials.gov Identifier:	NCT00180076
Health Authority:	Germany: Federal Institute for Drugs and Medicinal Device

Keywords provided by Dresden University of Technology:

collagenous colitis
microscopic colitis
budesonide

Study placed in the following topic categories:

Colitis, Microscopic
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Budesonide

Collagenous colitis
Colitis, Collagenous
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents
Peripheral Nervous System Agents
Hormones
Glucocorticoids
Bronchodilator Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009