Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065065
Status:
COMPLETED
Last Update Posted:
2018-01-16
First Post:
2003-07-16
Brief Title:
A Trial of Rosiglitazone for Ulcerative Colitis
Sponsor:
James Lewis
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Randomized Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter randomized double-blind placebo-controlled study evaluating rosiglitazone 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the treatment of mild to moderately active ulcerative colitis Disease activity will be measured using a standard disease activity index Calculation of the index requires patients to undergo flexible sigmoidoscopy at the start of the study and at week 12
Detailed Description:
Ulcerative colitis is a disease characterized by inflammation the changes that happen when tissues in the body are injured of all or a portion of the large intestine There is presently no medical cure for ulcerative colitis although surgical removal of the colon would cure the disease Ulcerative colitis is generally treated with medications against diarrhea and infection medications which suppress the immune system the body system that protects a person against foreign substances or with surgery
It is thought that the chronic inflammation associated with ulcerative colitis may be related to the release of certain chemicals produced by the body Rosiglitazone has been shown to inhibit the production of some of these chemicals The active component of rosiglitazone has also been shown to improve colitis in animal models of colitis The purpose of this study is to evaluate the benefit of the drug for ulcerative colitis by comparing it to placebo
This is a randomized controlled trial of rosiglitazone versus placebo in patients who have failed to respond to 5-ASA therapy Participants will be randomized to receive either rosiglitazone 4mg bid or placebo bid twice daily for a total of 12 weeks Disease activity will be measured using the Disease Activity Index DAI at visits 3 through 8 Additional outcomes measured will include histological disease activity visits 3 and 7 and quality of life using the IBDQ visits 3 through 8 The principle analyses will be an intent-to-treat analysis to examine the efficacy of rosiglitazone at a dose of 4mg twice daily compared to placebo to achieve a partial or complete response Additionally the change in NF-κB activation prior to and following therapy with either placebo or rosiglitazone will be examined using immunohistochemistry techniques
It is thought that the chronic inflammation associated with ulcerative colitis may be related to the release of certain chemicals produced by the body Rosiglitazone has been shown to inhibit the production of some of these chemicals The active component of rosiglitazone has also been shown to improve colitis in animal models of colitis The purpose of this study is to evaluate the benefit of the drug for ulcerative colitis by comparing it to placebo
This is a randomized controlled trial of rosiglitazone versus placebo in patients who have failed to respond to 5-ASA therapy Participants will be randomized to receive either rosiglitazone 4mg bid or placebo bid twice daily for a total of 12 weeks Disease activity will be measured using the Disease Activity Index DAI at visits 3 through 8 Additional outcomes measured will include histological disease activity visits 3 and 7 and quality of life using the IBDQ visits 3 through 8 The principle analyses will be an intent-to-treat analysis to examine the efficacy of rosiglitazone at a dose of 4mg twice daily compared to placebo to achieve a partial or complete response Additionally the change in NF-κB activation prior to and following therapy with either placebo or rosiglitazone will be examined using immunohistochemistry techniques
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK059961 | NIH | None | httpsreporternihgovquickSearchR01DK059961 |