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Senolytic Agent
Fisetin for Osteoarthritis
Phase 1 & 2
Waitlist Available
Led By Thomas A Evans, MD
Research Sponsored by Steadman Philippon Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are male or female, ages 40-80;
Are willing to comply with all study related procedures and assessments;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, and 12 months (post 1st drug dose)
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a drug called Fisetin for treating people with mild to moderate osteoarthritis.
Eligible Conditions
- Osteoarthritis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months, and 12 months (post 1st drug dose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, and 12 months (post 1st drug dose)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Change in levels of cartilage degenerating markers associated with OA
Change in levels of pro-inflammatory markers associated with Senescence
Change in muscle strength (Isokinetic Dynamometry)
+9 moreSide effects data
From 2022 Phase 2 trial • 55 Patients • NCT047716117%
Rash
7%
Chest pain
7%
Diarrhea
7%
Sinusitis
7%
Infectious Rash
7%
Back Pain
7%
Headache
7%
Worsening Headache
7%
Dyspnea
7%
sore throat
7%
hyperhidrosis
3%
tachycardia
3%
shortness of breath
3%
ageusia
3%
amnesia
3%
change in smell
3%
ear pain, left
3%
vomiting
3%
edema, hand, bilateral
3%
fatigue
3%
flu like symptoms
3%
Otitis media
3%
Upper Respiratory Infection
3%
Anosmia
3%
Colic Renal
3%
Nephrolithiasis Calcium Oxalate
3%
Epistaxis
3%
cough
3%
rhinitis
3%
sneezing
3%
thrush
3%
right shoulder arthroscopy, rotator cuff, repair
3%
asthma with exacerbation
3%
watering eyes (epiphora)
3%
flatulence
3%
conjunctivitis
3%
migraine
3%
bacterial vaginosis
3%
arthoplasty
3%
vertigo
3%
Systolic murmur
3%
hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FisetinExperimental Treatment1 Intervention
Fisetin 100 mg capsules (~20 mg/ kg/ day) will be administered orally for two consecutive days (days 1 and 2) followed by 28 days off. A second course will be given for two consecutive days (days 31 and 32)
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules will be administered orally for two consecutive days (days 1 and 2) followed by 28 days off. A second course will be given for two consecutive days (days 31 and 32)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisetin
2016
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
Office of Naval Research (ONR)FED
14 Previous Clinical Trials
647 Total Patients Enrolled
Steadman Philippon Research InstituteLead Sponsor
9 Previous Clinical Trials
540 Total Patients Enrolled
1 Trials studying Osteoarthritis
100 Patients Enrolled for Osteoarthritis
United States Department of DefenseFED
855 Previous Clinical Trials
225,371 Total Patients Enrolled
2 Trials studying Osteoarthritis
141 Patients Enrolled for Osteoarthritis
Frequently Asked Questions
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