Back to resultsTreatment With Local PPARgamma Ligand in Distal Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Rosiglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring PPARgamma ligand, Rosiglitazone, Enema
Eligibility Criteria
Inclusion Criteria: Distal ulcerative colitis (Mayo Clinical Score > 7) Age > 18 years Written consent Exclusion Criteria: Age < 18 years Severe ulcerative colitis Systemic treatment with steroids or azathioprin within the last 3 month Known liver or kidney disease Severe heart failure Pregnancy or breast feeding
Sites / Locations
- Dept. Gastroenterology C, Herlev University HospitalRecruiting
Outcomes
Primary Outcome Measures
Clinical response
Secondary Outcome Measures
Endoscopic response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00309660
Brief Title
Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Herlev Hospital
4. Oversight
5. Study Description
Brief Summary
Treatment with PPARgamma ligands have been shown to reduces intestinal inflammation in murine models of colitis. The aim of this study was to evaluate the effect of treatment with local PPARgamma ligand (rosiglitazone) in distal ulcerative colitis.The patients are treated with rosiglitazone enema, once a day, for fourteen days. Disease activity was assessed before and after treatment by endoscopical and clinical activity score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
PPARgamma ligand, Rosiglitazone, Enema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Primary Outcome Measure Information:
Title
Clinical response
Secondary Outcome Measure Information:
Title
Endoscopic response
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:
Distal ulcerative colitis (Mayo Clinical Score > 7)
Age > 18 years
Written consent
Exclusion Criteria:
Age < 18 years
Severe ulcerative colitis
Systemic treatment with steroids or azathioprin within the last 3 month
Known liver or kidney disease
Severe heart failure
Pregnancy or breast feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gitte Pedersen
Phone
+ 45 44883418
Email
gitped01@herlevhosp.kbhamt.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørn Brynskov, Ass. Prof.
Organizational Affiliation
Dept Gastroenterology C, Herlev University Hospital, 2730 Herlev, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Gastroenterology C, Herlev University Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gitte Pedersen, MD
Phone
+45 44883418
Email
gitped01@herlevhosp.kbhamt.dk
First Name & Middle Initial & Last Name & Degree
Gitte Pedersen, MD
12. IPD Sharing Statement
Learn more about this trial
Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis
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