Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

Phase 2

Withdrawn

• Conditions: Colorectal Cancer; Small Intestine Cancer

• Registration Number: NCT00026468
• Lead Sponsor: University of Utah

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.

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.

Study Timeline

• Study Start: 1999-07
• Primary Completion: 1999-07
• Study Completion: 1999-07
• Study First Submitted: 2001-11-09
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-23
• Last Update Posted: 2013-07-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP