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NCT01483144 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Familial Adenomatous Polyposis, sponsored by Cancer Prevention Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
171
Enrollment target
17
Study locations

NCT01483144: Completed Phase 3 study of Familial Adenomatous Polyposis, sponsored by Cancer Prevention Pharmaceuticals.

NCT01483144 is a Phase 3 study of Familial Adenomatous Polyposis that has completed, run by Cancer Prevention Pharmaceuticals. The registered enrollment target is 171 participants, below the 232-participant average among 10 other Familial Adenomatous Polyposis trials with a reported enrollment target (26% lower). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01483144, a Phase 3 study of Familial Adenomatous Polyposis, has completed, sponsored by Cancer Prevention Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
171 participants
Enrollment target
17
Study locations

Study 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.

Primary Outcome

Progression of disease by evaluation of FAP-related events over the course of study treatment

Conditions Studied

Familial Adenomatous Polyposis

Interventions

  • DRUG Eflornithine
  • DRUG Eflornithine Placebo
  • DRUG Sulindac 150 MG
  • DRUG Sulindac placebo

Study Locations (17)

Other

  • UZ Leuven - Leuven
  • University Hospital Bonn - Bonn
  • Academic Medical Centre - Amsterdam
  • Manchester Center for Genomic Medicine - Manchester

California

  • University of California San Diego - La Jolla

Georgia

  • Emory University - Atlanta

Massachusetts

  • Dana Farber Cancer Institute - Boston

Michigan

  • University of Michigan - Ann Arbor

Minnesota

  • Mayo Clinic - Rochester

Missouri

  • Washington University - St Louis

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 171 participants
Start Date 2013-10
Est. Completion 2019-03
Phase Phase 3
Cancer Prevention Pharmaceuticals

1 total trials

What the finished NCT01483144 record still lists

NCT01483144 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, below the 232-participant average among 10 other Familial Adenomatous Polyposis trials with a reported enrollment target (26% lower).

The record links to 1 condition, with Familial Adenomatous Polyposis appearing as the primary indexed condition, and to 4 interventions - of which Eflornithine is the first listed.

NCT01483144 lists 17 locations in 14 states (Other, California, Georgia).

Frequently Asked Questions

What is clinical trial NCT01483144 about?

NCT01483144 is a clinical study titled "Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)". 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...

What is the current status of trial NCT01483144?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 171 participants. The study started on 2013-10. Estimated completion is 2019-03.

What conditions does trial NCT01483144 study?

This clinical trial studies the following conditions: Familial Adenomatous Polyposis.

What interventions are being tested in trial NCT01483144?

The interventions under investigation include: Eflornithine (DRUG), Eflornithine Placebo (DRUG), Sulindac 150 MG (DRUG), Sulindac placebo (DRUG).

Who is sponsoring clinical trial NCT01483144?

This trial is sponsored by Cancer Prevention Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01483144 being conducted?

This trial has 17 study locations across California, Georgia, Massachusetts, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Familial Adenomatous Polyposis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01483144's enrollment target sits among peer trials

171 3rd of 10 higher than 8 of 10 other Familial Adenomatous Polyposis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Familial Adenomatous Polyposis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01483144, the US trial registry maintained by the National Library of Medicine. NCT01483144 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.