Budesonide Treatment for Lymphocytic Colitis
Primary Purpose
Microscopic 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 Microscopic Colitis focused on measuring lymphocytic colitis, microscopic colitis, budesonide
Eligibility Criteria
Inclusion Criteria: lymphocytic colitis diarrhea effective contraception written informed consent Exclusion Criteria: other forms if IBD celiac disease infectious colitis history of colonic surgery use of budesonide, 5-ASA, steroids within th previous 4 weeks pregnancy, lactation
Sites / Locations
- Medical Department I, Technical University Hospital
Outcomes
Primary Outcome Measures
Proportion of patients in clinical remission after 6 weeks
Secondary Outcome Measures
safety
quality of life
histological improvement
Full Information
NCT ID
NCT00180050
First Posted
September 9, 2005
Last Updated
March 29, 2010
Sponsor
Technische Universität Dresden
Collaborators
Dr. Falk Pharma GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00180050
Brief Title
Budesonide Treatment for Lymphocytic Colitis
Official Title
Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Technische Universität Dresden
Collaborators
Dr. Falk Pharma GmbH
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
Detailed Description
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microscopic Colitis
Keywords
lymphocytic colitis, microscopic colitis, budesonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (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 weeks
Secondary Outcome Measure Information:
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:
lymphocytic colitis
diarrhea
effective contraception
written informed consent
Exclusion Criteria:
other forms if IBD
celiac disease
infectious colitis
history of colonic surgery
use of budesonide, 5-ASA, steroids within th previous 4 weeks
pregnancy, lactation
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 Treatment for Lymphocytic Colitis
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