drugset
drugset / Trial / NCT01245816

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

NCT01245816 ↗

Phase 3 Withdrawn Cancer Prevention Pharmaceuticals, Inc.
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2011-03
Primary completion
2013-05
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Eflornithine Small molecule 500 mg Oral
Subject Sulindac Small molecule 150 mg Oral

Indications

classic familial adenomatous polyposis