Long-Term Treatment of Collagenous Colitis With Budesonide

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2005 by Bonderup, Ole K., M.D.. Recruitment status was Active, not recruiting

First Received on August 29, 2005. Last Updated on March 3, 2008 History of Changes

Sponsor:	Bonderup, Ole K., M.D.
Collaborator:	AstraZeneca
Information provided by:	Bonderup, Ole K., M.D.
ClinicalTrials.gov Identifier:	NCT00139165

Purpose

The aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms (number of daily stools)

Condition	Intervention	Phase
Collagenous Colitis	Drug: Budesonide Procedure: sigmoidoscopy	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:	Long-Term Treatment of Collagenous Colitis With Budesonide. Prospective, Doubleblind Placebo-Controlled Trial.

Resource links provided by NLM:

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Bonderup, Ole K., M.D.:

Primary Outcome Measures:

Clinical symptoms

Secondary Outcome Measures:

Histological changes

Estimated Enrollment:	36
Study Start Date:	September 2004
Estimated Study Completion Date:	March 2006

Intervention Details:

Capsule. Oral 6 mg o.d. for 24 weeks

Sigmoidoscopy performed 2 times during the study period.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological criteria of Collagenous colitis
Clinical activity (> 3 stools/day)

Exclusion Criteria:

Treatment of Collagenous colitis within the last 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139165

Locations

Denmark
Dept. of medical gastroenterology
Aalborg, Denmark, 9100
Dept. of medical gastroenterology
Aarhus, Denmark, 8000

Sponsors and Collaborators

Bonderup, Ole K., M.D.

AstraZeneca

Investigators

Principal Investigator:

Ole K Bonderup, MD

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00139165 History of Changes
Other Study ID Numbers:	okbon123
Study First Received:	August 29, 2005
Last Updated:	March 3, 2008
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Bonderup, Ole K., M.D.:

Collagenous colitis
Budesonide treatment
Diarrhea

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 09, 2012