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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
  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 1
Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Herlev Hospital:
PPARgamma ligand
Rosiglitazone
Enema

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

ClinicalTrials.gov processed this record on May 16, 2013