Long-Term Treatment of Collagenous Colitis With Budesonide

This study is ongoing, but not recruiting participants.

First Received: August 29, 2005 Last Updated: 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:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Unaffiliated

More Information

No publications provided

Study ID Numbers:	okbon123
Study First Received:	August 29, 2005
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00139165 History of Changes
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:

Anti-Inflammatory Agents
Respiratory System Agents
Colitis, Microscopic
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Colitis, Collagenous
Intestinal Diseases

Hormones
Glucocorticoids
Pharmacologic Actions
Digestive System Diseases
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Gastroenteritis
Colitis
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 09, 2009