Preventing Injured Knees From osteoArthritis: Severity Outcomes

Study acronym: PIKASO
StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2028 → Dec 2029
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Record History

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  1. Primary completion pushed from Dec 2028 to Dec 2029 Show 7 more changesShow less
    • Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital
    • Study completion pushed from Dec 2029 to Dec 2030
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 13 of 18 entries
    • Study description revised
    • Site details revised at 1 of 9 sites
    • Publications: details revised at 8 of 8 entries
  2. Eligibility criteria expanded, about 17 words
    • Site details revised at 9 of 9 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Dec 2023 to May 6, 2024
    • Secondary endpoints revised (18)
    • Study description revised
    • Site details revised at 9 of 9 sites
  4. Study First Submitted
  • 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 study is being done to find out if metformin is effective at reducing pain by delaying the onset of post-traumatic osteoarthritis (PTOA) after anterior cruciate ligament (ACL) reconstruction. This research study will compare metformin to placebo. The placebo tablet looks exactly like metformin, but contains no metformin. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat type II diabetes. Notably, it also has anti-inflammatory effects, suggesting it could benefit people who have an ACL injury and are undergoing ACL reconstruction.
Trial Details
NCT Number NCT06096259
Lead Sponsor Brigham and Women's Hospital
Collaborators: Arthritis Foundation
Conditions
(from sponsor)		 Osteoarthritis, Knee, Post-traumatic Osteoarthritis, ACL Tear
Related terms Anterior Cruciate Ligament Injuries, Osteoarthritis, Knee
Enrollment 512 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov