At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Eflornithine, Eflornithine Placebo, and 2 other interventions for Familial Adenomatous Polyposis. Completed, enrolled 171 participants across 17 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Eflornithine placebo \[three tablets orally once a day\]
Sulindac \[one tablet orally once a day\]
Sulindac placebo \[one tablet orally once a day\]