This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Herlev Hospital.
Recruitment status was:  Recruiting
Information provided by:
Herlev Hospital Identifier:
First received: March 30, 2006
Last updated: September 20, 2006
Last verified: September 2006
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
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00309660     History of Changes
Other Study ID Numbers: PPAR2005
Study First Received: March 30, 2006
Last Updated: September 20, 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 processed this record on August 21, 2017