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

Study:

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

Rationale:

n/a

Purpose:

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).

Study Status: Not yet recruiting

Recruiting:
n/a

Condition Intervention Phase
Familial Adenomatous Polyposis Drug: Eflornithine plus Sulindac
Drug: Eflornithine plus Placebo
Drug: Sulindac plus Placebo		 Phase 3

Verified by Cancer Prevention Pharmaceuticals, Inc. November, 2010

Sponsored by: Cancer Prevention Pharmaceuticals, Inc.
Information provided by: Cancer Prevention Pharmaceuticals, Inc.
ClinicalTrials.gov identifier: NCT01245816

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Alfred M. Cohen, M.D.., Study Director

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.