Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis

Phase 1

• Conditions: Ulcerative Colitis

• Registration Number: NCT00309660
• Lead Sponsor: Herlev Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-03-30
• Study First Submitted QC: 2006-03-31
• Study First Posted: 2006-04-03
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-20
• Last Update Posted: 2006-09-21
• Study Completion: 2007-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical response

Secondary Outcome Measures

Name	Time	Method
Endoscopic response

Trial Locations

Locations (1)

Dept. Gastroenterology C, Herlev University Hospital; 🇩🇰 Herlev, Denmark