Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis

Keywords

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PPARgamma ligand Rosiglitazone Enema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Rosiglitazone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jørn Brynskov, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Dept Gastroenterology C, Herlev University Hospital, 2730 Herlev, Denmark

Locations

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Dept. Gastroenterology C, Herlev University Hospital

Herlev, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Gitte Pedersen

Role: CONTACT

Phone: + 45 44883418

Email: [email protected]

Facility Contacts

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Gitte Pedersen, MD

Role: primary

Other Identifiers

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PPAR2005

Identifier Type: -

Identifier Source: org_study_id