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Long-Term Treatment of Collagenous Colitis With Budesonide

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Information provided by:

Study Description
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Clinical symptoms

Secondary Outcome Measures :
  1. Histological changes

Eligibility Criteria

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
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

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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov 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
Diarrhea

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