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

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active, not recruiting

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

key information

study id #: NCT01483144

condition: Familial Adenomatous Polyposis

status: active, not recruiting

purpose:

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.

intervention: Drug: Eflornithine plus Sulindac
Drug: Eflornithine and Placebo
Drug: Sulindac and Placebo

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