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

March 30, 2006
April 3, 2006
September 21, 2006
November 2005
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Clinical response
Same as current
Complete list of historical versions of study NCT00309660 on Archive Site
Endoscopic response
Same as current
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Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis
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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.
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Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Ulcerative Colitis
Drug: Rosiglitazone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2007
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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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Herlev Hospital
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Principal Investigator: Jørn Brynskov, Ass. Prof. Dept Gastroenterology C, Herlev University Hospital, 2730 Herlev, Denmark
Herlev Hospital
September 2006

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