NCT00309660

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

September 21, 2006

Status Verified

September 1, 2006

First QC Date

March 30, 2006

Last Update Submit

September 20, 2006

Conditions

Ulcerative Colitis

Keywords

PPARgamma ligandRosiglitazoneEnema

Outcome Measures

Primary Outcomes (1)

  • Clinical response

Secondary Outcomes (1)

  • Endoscopic response

Interventions

RosiglitazoneDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Distal ulcerative colitis (Mayo Clinical Score \> 7)
  • Age \> 18 years
  • Written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Gastroenterology C, Herlev University Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jørn Brynskov, Ass. Prof.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gitte Pedersen

CONTACT

+ 45 44883418gitped01@herlevhosp.kbhamt.dk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2006

First Posted

April 3, 2006

Study Start

November 1, 2005

Study Completion

June 1, 2007

Last Updated

September 21, 2006

Record last verified: 2006-09

Locations

DK(1)