Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026468
Status:
WITHDRAWN
Last Update Posted:
2013-07-24
First Post:
2001-11-09
Brief Title:
Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principle Investigator has left the University
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis
PURPOSE Randomized phase IIIII trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis
PURPOSE Randomized phase IIIII trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis
Detailed Description:
OBJECTIVES
Determine the ability of exisulind to inhibit growth and development of duodenal adenomas in patients with familial adenomatous polyposis
Determine the effect on apoptosis in polyp vs mucosal tissue in these patients when treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to one of two treatment arms
Arm I Patients receive oral exisulind 4 times daily
Arm II Patients receive oral placebo 4 times daily Treatment continues for 1 year
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
Determine the ability of exisulind to inhibit growth and development of duodenal adenomas in patients with familial adenomatous polyposis
Determine the effect on apoptosis in polyp vs mucosal tissue in these patients when treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to one of two treatment arms
Arm I Patients receive oral exisulind 4 times daily
Arm II Patients receive oral placebo 4 times daily Treatment continues for 1 year
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| NCI-H01-0079 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA042014 |
| R01CA080852 | NIH | None | None |
| P30CA042014 | NIH | None | None |
| UUMC-IRB-5999-96 | None | None | None |