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
Information provided by:
Bonderup, Ole K., M.D.
ClinicalTrials.gov Identifier:
First received: August 29, 2005
Last updated: March 3, 2008
Last verified: August 2005
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 3

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:

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:
    Drug: Budesonide
    Capsule. Oral 6 mg o.d. for 24 weeks
    Procedure: sigmoidoscopy
    Sigmoidoscopy performed 2 times during the study period.

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

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

Dept. of medical gastroenterology
Aalborg, Denmark, 9100
Dept. of medical gastroenterology
Aarhus, Denmark, 8000
Sponsors and Collaborators
Bonderup, Ole K., M.D.
Principal Investigator: Ole K Bonderup, MD
  More Information

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

Additional relevant MeSH terms:
Colitis, Collagenous
Colitis, Microscopic
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016