Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00026468|
Recruitment Status : Withdrawn (Principle Investigator has left the University.)
First Posted : January 27, 2003
Last Update Posted : July 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Small Intestine Cancer||Drug: exisulind||Phase 2 Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis|
|Study Start Date :||July 1999|
|Actual Primary Completion Date :||July 1999|
|Actual Study Completion Date :||July 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026468
|Study Chair:||James A. DiSario, MD||University of Utah|