A Trial of Rosiglitazone for Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00065065
Recruitment Status : Completed
First Posted : July 18, 2003
Results First Posted : December 2, 2014
Last Update Posted : January 16, 2018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
James Lewis, University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Ulcerative Colitis
Inflammatory Bowel Disease
Interventions: Drug: Rosiglitazone
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from 15 clinical centers between September 6, 2002 and January 11, 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Rosiglitazone rosiglitazone (Avandia): 4mg orally twice daily for 12 weeks
Placebo Placebo identical to study drug twice daily for 12 weeks

Participant Flow:   Overall Study
    Rosiglitazone   Placebo
STARTED   52   53 
COMPLETED   42   33 
NOT COMPLETED   10   20 
Adverse Event                3                2 
Withdrawal by Subject                1                5 
Lack of Efficacy                4                11 
Other                2                2 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Rosiglitazone rosiglitazone (Avandia): 4mg orally twice daily
Placebo Identical in appearance to study drug taken twice a day
Total Total of all reporting groups

Baseline Measures
   Rosiglitazone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   53   105 
[Units: Years]
Median (Inter-Quartile Range)
 (31 to 49) 
 (34 to 55) 
 (31 to 51) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      22  42.3%      19  35.8%      41  39.0% 
Male      30  57.7%      34  64.2%      64  61.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      2   3.8%      0   0.0%      2   1.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   1.9%      1   1.0% 
Black or African American      2   3.8%      2   3.8%      4   3.8% 
White      48  92.3%      50  94.3%      98  93.3% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
United States   52   53   105 

  Outcome Measures

1.  Primary:   Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Participants With Clinical Remission at 12 Weeks   [ Time Frame: 12 weeks ]

3.  Secondary:   Number of Participants With Endoscopic Remission at 12 Weeks   [ Time Frame: 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: James D. Lewis, MD, MSCE
Organization: University of Pennsylvania
phone: 215-573-5137

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: James Lewis, University of Pennsylvania Identifier: NCT00065065     History of Changes
Other Study ID Numbers: ROSIE
R01DK059961 ( U.S. NIH Grant/Contract )
First Submitted: July 16, 2003
First Posted: July 18, 2003
Results First Submitted: July 10, 2014
Results First Posted: December 2, 2014
Last Update Posted: January 16, 2018