NCT00567593

Brief Summary

The purpose of this study is to determine the effect of rosiglitazone on the genes of the colon

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

May 8, 2014

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

December 3, 2007

Results QC Date

December 20, 2013

Last Update Submit

July 3, 2016

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • PDK4 mRNA

    14 days

Study Arms (1)

Rosiglitazone

OTHER

Rosiglitazone; 8mg tablet once a day for 14 days

Drug: Rosiglitazone

Interventions

RosiglitazoneDRUG

8mg tablet once a day for 14 days

Also known as: Avandia
Rosiglitazone

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Capable of giving informed consent
  • Agrees to use a barrier method of birth control for the duration of the study

You may not qualify if:

  • History of inflammatory bowel disease
  • Has taken prescription or over the counter medications in the two weeks prior to enrollment
  • History of diabetes, heart failure, angina, hypertension, coronary heart disease, cancer, bleeding disorder, HIV, AIDS
  • Fasting LDL \>160 mg/dl
  • History of smoking in the year prior to enrollment
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Clinical and Translational Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
James D. Lewis, MD, MSCE
Organization
University of Pennsylvania
lewisjd@mail.med.upenn.edu
215-573-5137

Study Officials

  • James D Lewis, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine and Epidemiology

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 5, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

August 1, 2016

Results First Posted

May 8, 2014

Record last verified: 2016-07

Locations

US(1)