Treatment With Local PPARgamma Ligand in Distal Ulcerativ... | NCT00309660

Studies
Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis

NCT00309660

Sponsor

Herlev Hospital

Status

Unknown status

Last Update Posted

Sep 21, 2006Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Ulcerative Colitis

Interventions

Rosiglitazone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Jun 2007

First Submitted Date

Mar 30, 2006

First Submission Date that Met QC Criteria

Mar 31, 2006

First Posted Date

Apr 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2006

Last Update Posted Date

Sep 21, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Rosiglitazone	Drug

Measure	Description	Time Frame
Clinical response

Measure	Description	Time Frame
Endoscopic response

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gitte Pedersen	Contact	+ 45 44883418		gitped01@herlevhosp.kbhamt.dk

Overall Officials

Name	Affiliation	Role
Jørn Brynskov, Ass. Prof.	Dept Gastroenterology C, Herlev University Hospital, 2730 Herlev, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Gastroenterology C, Herlev University Hospital	Recruiting	Herlev		2730	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077154	Rosiglitazone

Ancestor Terms

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided