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Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis

H

Herlev Hospital

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Ulcerative Colitis

Treatments

Drug: Rosiglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT00309660
PPAR2005

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Central trial contact

Gitte Pedersen

Data sourced from clinicaltrials.gov

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