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NCT00004161 · ClinicalTrials.gov registry record · Phase 2

Fenretinide in Treating Patients With Leukoplakia of the Mouth

A Phase 2 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT00004161: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.

NCT00004161 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00004161, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. Fenretinide may be an effective drug in treating leukoplakia. PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide in treating patients who have leukoplakia of the mouth.

Interventions

  • DRUG Placebo
  • DRUG fenretinide

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 1997-06
Est. Completion 2004-01
Phase Phase 2
University of Alabama at Birmingham

1,160 total trials

What the finished NCT00004161 record still lists

NCT00004161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00004161 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00004161 about?

NCT00004161 is a clinical study titled "Fenretinide in Treating Patients With Leukoplakia of the Mouth". RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. Fenretinide may be an effective drug in treating leukoplakia. PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide in treating patients who have leukopl...

What is the current status of trial NCT00004161?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 1997-06. Estimated completion is 2004-01.

What interventions are being tested in trial NCT00004161?

The interventions under investigation include: Placebo (DRUG), fenretinide (DRUG).

Who is sponsoring clinical trial NCT00004161?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00004161's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00004161, the US trial registry maintained by the National Library of Medicine. NCT00004161 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.