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NCT05727761 · ClinicalTrials.gov registry record · Phase 2
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
A Phase 2 study of Oral Leukoplakia, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT05727761: Recruiting Phase 2 study of Oral Leukoplakia, sponsored by University of Minnesota.
NCT05727761 is a Phase 2 study of Oral Leukoplakia that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 36 participants, below the 41-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (12% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05727761, a Phase 2 study of Oral Leukoplakia, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks. The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin. Outcomes are defined as are a reduction of the leukoplakia grade in \> 50% of treated participants and a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions. In addition, participants who show clinical and histologic improvement should correlate with a significant reduction of Ki-67 proliferative indices in lesions of these participants as compared to baseline.
Primary Outcome
a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions
Conditions Studied
Interventions
- DRUG pioglitazone-metformin
Study Locations (2)
Minnesota
- University of Minnesota - Minneapolis
- HealthPartners - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2026-07-28 |
| Phase | Phase 2 |
What NCT05727761 shows while recruiting
NCT05727761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 41-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (12% lower).
The record links to 1 condition, with Oral Leukoplakia appearing as the primary indexed condition, and to 1 intervention - of which pioglitazone-metformin is the first listed.
NCT05727761 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05727761 about?
NCT05727761 is a clinical study titled "Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia". This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks. The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin. Outcomes are defined a...
What is the current status of trial NCT05727761?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-01-01. Estimated completion is 2026-07-28.
What conditions does trial NCT05727761 study?
This clinical trial studies the following conditions: Oral Leukoplakia.
What interventions are being tested in trial NCT05727761?
The interventions under investigation include: pioglitazone-metformin (DRUG).
Who is sponsoring clinical trial NCT05727761?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05727761 being conducted?
This trial has 2 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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