Budesonide for Maintenance Treatment of Collagenous Colitis

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00180076
First received: September 9, 2005
Last updated: March 29, 2010
Last verified: March 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00180076     History of Changes
Other Study ID Numbers: MIMIC
Study First Received: September 9, 2005
Last Updated: March 29, 2010
Health Authority: Germany: Federal Institute for Drugs and Medicinal Device

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
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 July 22, 2014