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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
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Bonderup, Ole K., M.D.
ClinicalTrials.gov Identifier:
NCT00139165
First received: August 29, 2005
Last updated: March 3, 2008
Last verified: August 2005
History of Changes
  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 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:

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:
    Drug: Budesonide
    Capsule. Oral 6 mg o.d. for 24 weeks
    Procedure: sigmoidoscopy
    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 June 17, 2013