Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2006 by Herlev Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Herlev Hospital

ClinicalTrials.gov Identifier:

NCT00309660

First received: March 30, 2006

Last updated: September 20, 2006

Last verified: September 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2006

Last Updated Date

September 20, 2006

Start Date ^ICMJE

November 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Clinical response

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00309660 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Endoscopic response

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis

Official Title ^ICMJE

Not Provided

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Condition ^ICMJE

Ulcerative Colitis

Intervention ^ICMJE

Drug: Rosiglitazone

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Gitte Pedersen

+ 45 44883418

gitped01@herlevhosp.kbhamt.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00309660

Other Study ID Numbers ^ICMJE

PPAR2005

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Herlev Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jørn Brynskov, Ass. Prof.

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

Information Provided By

Herlev Hospital

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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