Long-Term Treatment of Collagenous Colitis With Budesonide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00139165
Recruitment Status : Unknown
Verified August 2005 by Bonderup, Ole K., M.D..
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2005
Last Update Posted : March 6, 2008
Information provided by:
Bonderup, Ole K., M.D.

Brief Summary:
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 or disease Intervention/treatment Phase
Collagenous Colitis Drug: Budesonide Procedure: sigmoidoscopy Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Long-Term Treatment of Collagenous Colitis With Budesonide. Prospective, Doubleblind Placebo-Controlled Trial.
Study Start Date : September 2004
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Clinical symptoms

Secondary Outcome Measures :
  1. Histological changes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00139165     History of Changes
Other Study ID Numbers: okbon123
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: March 6, 2008
Last Verified: August 2005

Keywords provided by Bonderup, Ole K., M.D.:
Collagenous colitis
Budesonide treatment

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