Back to resultsBudesonide for Maintenance Treatment of Collagenous Colitis
Primary Purpose
Collagenous Colitis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Budesonide
Sponsored by
About this trial
This is an interventional treatment trial for Collagenous Colitis focused on measuring collagenous colitis, microscopic colitis, budesonide
Eligibility 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
Sites / Locations
- Medical Department I, Technical University Hospital
Outcomes
Primary Outcome Measures
Proportion of patients in clinical remission after 6 months
Secondary Outcome Measures
time to relapse
safety
quality of life
histological improvement
Full Information
NCT ID
NCT00180076
First Posted
September 9, 2005
Last Updated
March 29, 2010
Sponsor
Technische Universität Dresden
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT00180076
Brief Title
Budesonide for Maintenance Treatment of Collagenous Colitis
Official Title
Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Technische Universität Dresden
Collaborators
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.
Detailed Description
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Collagenous Colitis
Keywords
collagenous colitis, microscopic colitis, budesonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Budesonide
Primary Outcome Measure Information:
Title
Proportion of patients in clinical remission after 6 months
Secondary Outcome Measure Information:
Title
time to relapse
Title
safety
Title
quality of life
Title
histological improvement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Miehlke, Prof.
Organizational Affiliation
Medical Department I, Technical University Hospital, Dresden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Department I, Technical University Hospital
City
Dresden
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Budesonide for Maintenance Treatment of Collagenous Colitis
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