MedTrace Logo

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

NCT01245816 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-04-24

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Eflornithine plus Sulindac

Eflornithine, 250 mg tablet, two tablets (500 mg) orally once a day; Sulindac, 150 mg tablet, one tablet orally once a day

DRUG

Eflornithine plus Placebo

Eflornithine, 250 mg tablet, two tablets (500 mg) orally once a day; Placebo, one tablet orally once a day

DRUG

Sulindac plus Placebo

Sulindac, 150 mg tablet, one tablet orally once a day; Placebo, two tablets orally once a day

Sponsors & Collaborators

  • Cancer Prevention Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Alfred M. Cohen, M.D. · Cancer Prevention Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-05-31
Completion
2013-06-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245816 on ClinicalTrials.gov