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Budesonide for Maintenance Treatment of Collagenous Colitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180076
First Posted: September 16, 2005
Last Update Posted: March 30, 2010
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.
Collaborator:
AstraZeneca
Information provided by:
Technische Universität Dresden
  Purpose
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Condition Intervention Phase
Collagenous Colitis Drug: Budesonide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Proportion of patients in clinical remission after 6 months

Secondary Outcome Measures:
  • time to relapse
  • safety
  • quality of life
  • histological improvement

Estimated Enrollment: 75
Study Start Date: July 2004
Estimated Study Completion Date: March 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • collagenous colitis
  • diarrhea
  • written informed consent

Exclusion Criteria:

  • infectious causes for diarrhea
  • other inflammatory bowel diseases
  • history of colonic surgery
  • celiac disease
  • malignancies
  • severe concomitant diseases
  • use of budesonide, steroids, mesalazine within the previous 2 weeks
  • known intolerance to budesonide
  • history of lack of response to budesonide
  • pregnancy,lactation
  • drug and/or alcohol abuse
  • lack of compliance
  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): NCT00180076


Locations
Germany
Medical Department I, Technical University Hospital
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
AstraZeneca
Investigators
Principal Investigator: Stephan Miehlke, Prof. Medical Department I, Technical University Hospital, Dresden, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00180076     History of Changes
Other Study ID Numbers: MIMIC
First Submitted: September 9, 2005
First Posted: September 16, 2005
Last Update Posted: March 30, 2010
Last Verified: March 2010

Keywords provided by Technische Universität Dresden:
collagenous colitis
microscopic colitis
budesonide

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