NCT01483144

Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Cancer Prevention Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Familial Adenomatous Polyposis

Interventions

Type	Name	Description
DRUG	Eflornithine	Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
DRUG	Eflornithine Placebo	Eflornithine placebo \[three tablets orally once a day\]
DRUG	Sulindac 150 MG	Sulindac \[one tablet orally once a day\]
DRUG	Sulindac placebo	Sulindac placebo \[one tablet orally once a day\]

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-11-01
• Completion: 2019-03-01
• First posted: 2011-12-01
• Last updated: 2021-06-08
• Results posted: 2021-06-08

Locations

17 sites across 7 countries: United States, Belgium, Canada, Germany, Netherlands, Spain, United Kingdom