NCT01245816

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cancer Prevention Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Familial Adenomatous Polyposis

Interventions

Type	Name	Description
DRUG	Eflornithine plus Sulindac	Eflornithine, 250 mg tablet, two tablets (500 mg) orally once a day; Sulindac, 150 mg tablet, one tablet orally once a day
DRUG	Eflornithine plus Placebo	Eflornithine, 250 mg tablet, two tablets (500 mg) orally once a day; Placebo, one tablet orally once a day
DRUG	Sulindac plus Placebo	Sulindac, 150 mg tablet, one tablet orally once a day; Placebo, two tablets orally once a day

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-05-01
• Completion: 2013-06-01
• First posted: 2010-11-23
• Last updated: 2015-04-24