Budesonide for Maintenance Treatment of Collagenous Colitis

This study has been completed.

First Received on September 9, 2005. Last Updated on March 29, 2010 History of Changes

Sponsor:	Dresden University of Technology
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis

Resource links provided by NLM:

Drug Information available for: Budesonide

U.S. FDA Resources

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:	March 2008
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

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

Locations

Germany
Medical Department I, Technical University Hospital
Dresden, Germany, 01307

Sponsors and Collaborators

Dresden University of Technology

AstraZeneca

Investigators

Principal Investigator:

Stephan Miehlke, Prof.

Medical Department I, Technical University Hospital, Dresden, Germany

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00180076 History of Changes
Other Study ID Numbers:	MIMIC
Study First Received:	September 9, 2005
Last Updated:	March 29, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medicinal Device

Keywords provided by Dresden University of Technology:

collagenous colitis
microscopic colitis
budesonide

Additional relevant MeSH terms:

Colitis
Colitis, Collagenous
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Colitis, Microscopic
Budesonide
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 12, 2012