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Sponsors and Collaborators: |
Bonderup, Ole K., M.D. AstraZeneca |
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Information provided by: | Bonderup, Ole K., M.D. |
ClinicalTrials.gov Identifier: | NCT00139165 |
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 |
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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. |
Estimated Enrollment: | 36 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | March 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Dept. of medical gastroenterology | |
Aalborg, Denmark, 9100 | |
Dept. of medical gastroenterology | |
Aarhus, Denmark, 8000 |
Principal Investigator: | Ole K Bonderup, MD | Unaffiliated |
Study ID Numbers: | okbon123 |
Study First Received: | August 29, 2005 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00139165 |
Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Collagenous colitis Budesonide treatment Diarrhea |
Colitis, Microscopic Digestive System Diseases Diarrhea Gastrointestinal Diseases Colonic Diseases Budesonide |
Collagenous colitis Colitis, Collagenous Intestinal Diseases Gastroenteritis Colitis |
Anti-Inflammatory Agents Respiratory System Agents Autonomic Agents Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Asthmatic Agents Peripheral Nervous System Agents Hormones Glucocorticoids Bronchodilator Agents Pharmacologic Actions |