Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05727761 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 28, 2026 → Jul 30, 2027
See other at-risk trials from University of Minnesota

Record History

  1. Primary and study completion pushed from Jul 28, 2026 to Jul 30, 2027v9
  2. Study sites: 1 to 2v8
  3. Start date: Oct 1, 2024 to Jan 1, 2025
    • Primary completion date: Oct 1, 2026 to Jul 28, 2026
    • Study completion date: Oct 1, 2027 to Jul 28, 2026
    v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v6
  5. Primary completion date: Aug 31, 2025 to Oct 1, 2026v5 Show 4 more changesShow less
    • Start date: Aug 31, 2023 to Oct 1, 2024
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: Aug 31, 2026 to Oct 1, 2027
    • Site details revised
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Mar 15, 2026 to Aug 31, 2025
    • Study completion date: Mar 15, 2027 to Aug 31, 2026
    • Start date changed from estimate of Jun 15, 2024 to Aug 31, 2023
    • Site details revised
  2. Start date: Mar 15, 2024 to Jun 15, 2024v3
  3. Primary completion date: Aug 31, 2025 to Mar 15, 2026
    • Start date: Aug 31, 2023 to Mar 15, 2024
    • Study completion date: Aug 31, 2026 to Mar 15, 2027
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05727761
Lead Sponsor University of Minnesota
Conditions
(from sponsor)		 Oral Leukoplakia
Related terms Leukoplakia, Oral
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov