Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-28 @ 5:45 AM
Study NCT ID:
NCT00026468
Status:
WITHDRAWN
Last Update Posted:
2013-07-24
First Post:
2001-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis
Sponsor:
University of Utah
Organization:
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WITHDRAWN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 II/III 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 II/III 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA080852 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA042014 | NIH | None | https://reporter.nih.gov/quic… | View |
| UUMC-IRB-5999-96 | None | None | View | |
| NCI-H01-0079 | None | None | View |