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PBM and Topical Diclofenac in Knee Osteoarthritis
NCT07079969Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Apr 2026
- Primary completion
- Jul 2026
- Countries
- 1
- Sponsor
- University of Florida
- Modality
- Transdermal Patches, Hydrogel Systems, Small Molecules
- Drugs
- diclofenac
- Conditions
- knee osteoarthritis (OA)
01
Overview
Phase 2, randomised, double-blind trial of diclofenac in knee osteoarthritis (OA) (4 arms), sponsored by University of Florida. Primary endpoint: Change in Knee Pain Intensity (Numeric Rating Scale). Planned start Apr 2026; status: not yet recruiting.
02
Design
4 arms- Study design
- RandomizedDouble-blind
PBM Only
Placebo topical cream + Active PBM
Diclofenac only
Diclofenac cream + Sham PBM
Combined
Diclofenac cream + Active PBM
Double placebo
Placebo cream + Sham PBM
03
Who it enrols
Patients aged >= 50 with clinically confirmed knee osteoarthritis and symptomatic pain for >= 3 months, with average knee-pain intensity >= 30/100. Excludes patients with systemic rheumatic diseases, recent knee surgery or injections, daily opioid therapy, uncontrolled hypertension, severe renal or hepatic impairment, and uncontrolled diabetes.
04
Endpoints
Primary
Change in Knee Pain Intensity (Numeric Rating Scale)
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