Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis

This study is currently recruiting participants.

Verified by Herlev Hospital, September 2006

Sponsored by:	Herlev Hospital
Information provided by:	Herlev Hospital
ClinicalTrials.gov Identifier:	NCT00309660

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: Rosiglitazone	Phase I Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:

Clinical response

Secondary Outcome Measures:

Endoscopic response

Estimated Enrollment:	20
Study Start Date:	November 2005
Estimated Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309660

Contacts

Contact: Gitte Pedersen

+ 45 44883418

gitped01@herlevhosp.kbhamt.dk

Locations

Denmark
Dept. Gastroenterology C, Herlev University Hospital	Recruiting
Herlev, Denmark, 2730
Contact: Gitte Pedersen, MD +45 44883418 gitped01@herlevhosp.kbhamt.dk
Principal Investigator: Gitte Pedersen, MD

Sponsors and Collaborators

Herlev Hospital

Investigators

Principal Investigator:

Jørn Brynskov, Ass. Prof.

Dept Gastroenterology C, Herlev University Hospital, 2730 Herlev, Denmark

More Information

Study ID Numbers:	PPAR2005
Study First Received:	March 30, 2006
Last Updated:	September 20, 2006
ClinicalTrials.gov Identifier:	NCT00309660
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Herlev Hospital:

PPARgamma ligand
Rosiglitazone
Enema

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases

Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Rosiglitazone
Colitis

Additional relevant MeSH terms:

Hypoglycemic Agents
Pathologic Processes
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009