Who is sponsoring NCT01483144?

NCT01483144 is sponsored by Cancer Prevention Pharmaceuticals, Inc..

What condition does NCT01483144 study?

NCT01483144 studies Familial Adenomatous Polyposis.

What drugs are being tested in NCT01483144?

Interventions: Eflornithine, Eflornithine Placebo, Sulindac 150 MG, Sulindac placebo.

What is the status of NCT01483144?

NCT01483144 is currently COMPLETED.

Last reviewed 2021-05-12 · How we verify

Phase III Trial of the Safety and Efficacy of Eflornithine Combined With Sulindac Compared to Eflornithine, Sulindac as Single Agents in Patients With Familial Adenomatous Polyposis

NCT01483144 Phase 3 COMPLETED Results posted

The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event. This includes: 1) FAP related disease progression indicating the need for excisional intervention involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death.

Details

Lead sponsor	Cancer Prevention Pharmaceuticals, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	171
Start date	2013-10
Completion	2019-03

Conditions

Familial Adenomatous Polyposis

Interventions

Eflornithine
Eflornithine Placebo
Sulindac 150 MG
Sulindac placebo

Primary outcomes

Number of Subjects With Any FAP-related Event. — Up to 48 months from the start of treatment
Progression of disease by evaluation of FAP-related events over the course of study treatment

Countries

United States, Belgium, Canada, Germany, Netherlands, Spain, United Kingdom