Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309660
Recruitment Status : Unknown
Verified September 2006 by Herlev Hospital.
Recruitment status was:  Recruiting
First Posted : April 3, 2006
Last Update Posted : September 21, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Rosiglitazone Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : November 2005
Estimated Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Clinical response

Secondary Outcome Measures :
  1. Endoscopic response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00309660

Contact: Gitte Pedersen + 45 44883418

Dept. Gastroenterology C, Herlev University Hospital Recruiting
Herlev, Denmark, 2730
Contact: Gitte Pedersen, MD    +45 44883418   
Principal Investigator: Gitte Pedersen, MD         
Sponsors and Collaborators
Herlev Hospital
Principal Investigator: Jørn Brynskov, Ass. Prof. Dept Gastroenterology C, Herlev University Hospital, 2730 Herlev, Denmark Identifier: NCT00309660     History of Changes
Other Study ID Numbers: PPAR2005
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: September 21, 2006
Last Verified: September 2006

Keywords provided by Herlev Hospital:
PPARgamma ligand

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Hypoglycemic Agents
Physiological Effects of Drugs