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

NCT01483144 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2021-06-08

Study results available
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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.

Conditions

Interventions

DRUG

Eflornithine

Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]

DRUG

Eflornithine Placebo

Eflornithine placebo \[three tablets orally once a day\]

DRUG

Sulindac 150 MG

Sulindac \[one tablet orally once a day\]

DRUG

Sulindac placebo

Sulindac placebo \[one tablet orally once a day\]

Sponsors & Collaborators

  • Cancer Prevention Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Carol Burke, M.D. · The Cleveland Clinic

  • James Church, M.D. · The Cleveland Clinic

  • Gabriella Möslein, M.D. · Helios Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-11-30
Completion
2019-03-31

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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 NCT01483144 on ClinicalTrials.gov