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NCT00951379 · ClinicalTrials.gov registry record · Phase 2
Pioglitazone for Oral Premalignant Lesions
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT00951379: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00951379 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00951379, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn how Actos (pioglitazone) may affect oral premalignant lesions (OPLs) and/or the risk of mouth cancer. The safety of this drug will also be studied.
Primary Outcome
Overall Dichotomized Clinical and Histologic Response defined as 50% or greater reduction in sum of the measured products of perpendicular dimensions of the target lesion(s) or improvement in the degree of dysplasia or hyperplasia where complete (CR) or partial response (PR) in either clinical or histologic outcome assessed according to criteria given recorded as Response or No Response and analyzed as a dichotomous variable. Clinical Response = CR: Disappearance all evidence target \& non-targe
Interventions
- OTHER laboratory biomarker analysis
- OTHER placebo
- DRUG Pioglitazone hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2010-02 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
Why NCT00951379 stopped before completion
NCT00951379 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT00951379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00951379 about?
NCT00951379 is a clinical study titled "Pioglitazone for Oral Premalignant Lesions". The goal of this clinical research study is to learn how Actos (pioglitazone) may affect oral premalignant lesions (OPLs) and/or the risk of mouth cancer. The safety of this drug will also be studied.
What is the current status of trial NCT00951379?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2010-02. Estimated completion is 2014-03.
What interventions are being tested in trial NCT00951379?
The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), Pioglitazone hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00951379?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00951379's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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