Who is sponsoring NCT00118365?

NCT00118365 is sponsored by National Cancer Institute (NCI).

What condition does NCT00118365 study?

NCT00118365 studies Precancerous Condition.

What drugs are being tested in NCT00118365?

Interventions: placebo, eflornithine, sulindac, laboratory biomarker analysis.

What is the status of NCT00118365?

NCT00118365 is currently COMPLETED.

Last reviewed 2015-01-12 · How we verify

A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Combination of DFMO and Sulindac to Decrease the Rate of Recurrence of Adenomatous Polyps in the Colon

NCT00118365 Phase 3 COMPLETED Results posted

This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer

Details

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 3
Status	COMPLETED
Enrolment	375
Start date	1998-07
Completion	2008-08

Conditions

Precancerous Condition

Interventions

placebo
eflornithine
sulindac
laboratory biomarker analysis

Primary outcomes

Detection of Any Adenoma at the End of the Study — Up to 36 months
Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.

Countries

United States