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NCT06096259 · ClinicalTrials.gov registry record · Phase 2

Preventing Injured Knees From osteoArthritis: Severity Outcomes

A Phase 2 study of Osteoarthritis, Knee and Post-traumatic Osteoarthritis, sponsored by Brigham and Women's Hospital.

Recruiting
Registry status
Phase 2
Development phase
512
Enrollment target
9
Study locations

NCT06096259 is a Phase 2 study of Osteoarthritis, Knee and Post-traumatic Osteoarthritis that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 512 participants, below the 574-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (11% lower). The trial reports 9 study locations across 8 states.

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The verdict

NCT06096259, a Phase 2 study of Osteoarthritis, Knee and Post-traumatic Osteoarthritis, is actively recruiting participants, sponsored by Brigham and Women's Hospital.

RECRUITING
Registry status
Phase 2
Development phase
512 participants
Enrollment target
9
Study locations

Study Summary

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.

Conditions Studied

Osteoarthritis, Knee Post-traumatic Osteoarthritis ACL Tear

Interventions

  • DRUG Placebo
  • DRUG Metformin

Study Locations (9)

Ohio

  • Cleveland Clinic - Cleveland
  • The Ohio State University - Columbus

Georgia

  • Emory University - Atlanta

Iowa

  • University of Iowa Hospitals and Clinics - Iowa City

Kentucky

  • University of Kentucky - Lexington

Massachusetts

  • Brigham and Women's Hospital - Boston

Nebraska

  • University of Nebraska Medical Center - Omaha

New York

  • Hospital for Special Surgery - New York

North Carolina

  • The University of North Carolina at Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 512 participants
Start Date 2024-05-06
Est. Completion 2029-12
Phase Phase 2

Sponsor

Brigham and Women's Hospital

937 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06096259

The ClinicalTrials.gov registry entry for NCT06096259 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 512 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 574-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (11% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06096259 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Ohio, Georgia, Iowa.

Frequently Asked Questions

What is clinical trial NCT06096259 about?

NCT06096259 is a clinical study titled "Preventing Injured Knees From osteoArthritis: Severity Outcomes". 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,...

What is the current status of trial NCT06096259?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 512 participants. The study started on 2024-05-06. Estimated completion is 2029-12.

What conditions does trial NCT06096259 study?

This clinical trial studies the following conditions: Osteoarthritis, Knee, Post-traumatic Osteoarthritis, ACL Tear.

What interventions are being tested in trial NCT06096259?

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

Who is sponsoring clinical trial NCT06096259?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06096259 being conducted?

This trial has 9 study locations across Georgia, Iowa, Kentucky, Massachusetts, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.