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COMPLETED Phase 3

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

NCT01483144 · View on ClinicalTrials.gov ↗

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.

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01483144

The ClinicalTrials.gov registry entry for NCT01483144 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 171 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cancer Prevention Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01483144 reports 17 study locations spanning 14 distinct geographic areas — top geographies include Other, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01483144?

This trial is sponsored by Cancer Prevention Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial