NCT00026468

Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Small Intestine Cancer

Interventions

Type	Name	Description
DRUG	exisulind

Timeline

• Start date: 1999-07-01
• Primary completion: 1999-07-01
• Completion: 1999-07-01
• First posted: 2003-01-27
• Last updated: 2013-07-24