CompletedPhase 1/2

Senolytic Drugs Attenuate Osteoarthritis-Related Articular Cartilage Degeneration: A Clinical Trial

United States75 participantsStarted 2020-01-06

Plain-language summary

Phase I/II randomized, double-blind, placebo-controlled clinical trial to test the safety and efficacy of Fisetin for treating mild to moderate osteoarthritis

Who can participate

Age range40 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Are male or female, ages 40-80;
✓. Are willing to comply with all study related procedures and assessments;
✓. Are ambulatory as defined by ability to complete functional performance testing;
✓. Radiographic evidence of Kellgren-Lawrence grade II-IV osteoarthritis in one or both knees;
✓. Scores 4-10 on the Numerical Rating Scale (NRS) for pain;
✓. Stable dose of screening/baseline medications for at least 2 months prior to the anticipated date of study drug dosing.

Exclusion criteria

✕. Females who are nursing, pregnant or planning to become pregnant during the duration of study drug dosing;
✕. Males who do not wish to abstain from sex or use contraceptive protection during study drug dosing and for 2 weeks after the last dose;
✕. Subjects who do not have the capacity to consent themselves;
✕. Subjects who are unable to tolerate oral medication;
✕. Subjects having previously undergone any of the following treatments in the stated time window.
✕. Subjects with any of the following drug/medication statuses:
✕. Subjects with any of the following disease statuses:
✕. Subjects unable to safely practically undergo an MRI (BMI \> 40 kg/m2) or size exceeding limits of MRI equipment, implanted metal in study knee near joint surface, incompatible implant/device, severe claustrophobia;

What they're measuring

Number of Participants Experiencing One or More Treatment-Emergent Adverse Event

Timeframe: Duration of study, an average of 12 months

Trial details

NCT IDNCT04210986

SponsorSteadman Philippon Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-05

Results submitted2024-03-29

View on ClinicalTrials.gov More Osteoarthritis, Knee trials