Who is sponsoring NCT01245816?

NCT01245816 is sponsored by Cancer Prevention Pharmaceuticals, Inc..

What condition does NCT01245816 study?

NCT01245816 studies Familial Adenomatous Polyposis.

What drugs are being tested in NCT01245816?

Interventions: Eflornithine plus Sulindac, Eflornithine plus Placebo, Sulindac plus Placebo.

What is the status of NCT01245816?

NCT01245816 is currently WITHDRAWN.

Last reviewed 2015-04-23 · How we verify

A Randomized Phase III Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP)

NCT01245816 Phase 3 WITHDRAWN

The purpose of this phase III study is to evaluate the safety and efficacy of the combination of eflornithine and sulindac compared to single agent sulindac or eflornithine in reducing the number of polyps in patients with familial adenomatous polyposis (FAP).

Details

Lead sponsor	Cancer Prevention Pharmaceuticals, Inc.
Phase	Phase 3
Status	WITHDRAWN
Start date	2011-03
Completion	2013-06

Conditions

Familial Adenomatous Polyposis

Interventions

Eflornithine plus Sulindac
Eflornithine plus Placebo
Sulindac plus Placebo

Primary outcomes

Efficacy of Eflornithine plus Sulindac compared to Eflornithine alone and Sulindac alone determined by change in the number of polyps 2 mm or greater in a defined focal area of the rectum or pouch at baseline and after completion of the study treatment. — 6 months from the start of treatment.