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Available in the Gosset platform where reported.
01
Overview
Phase 2, randomised, double-blind trial of motys in knee osteoarthritis (OA) (3 arms), sponsored by Bioventus. Primary endpoints: Change from pretreatment baseline in the WOMAC pain subscale at 6 months and Incidence of local and systemic AEs at 6 months. Status: unknown.
02
Design
3 arms- Study design
- RandomizedDouble-blind
PTP-001 200 mg
Single IA injection of 200 mg PTP-001
PTP-001 100 mg
Single IA injection of 100 mg PTP-001
Placebo
Single IA injection of saline
03
Who it enrols
Patients aged 40-80 with symptomatic knee OA (Kellgren-Lawrence 2 or 3) and moderate pain (WOMAC NRS 20-40) who have failed analgesics/NSAIDs.
04
Endpoints
Primary
Change from pretreatment baseline in the WOMAC pain subscale
Incidence of local and systemic AEs
Secondary
Change from pretreatment baseline in pain intensity assessed by participant self report (WOMAC Pain subscale)
Change from pretreatment baseline in function assessed by participant self-report (WOMAC Function subscale)
Change from pretreatment baseline in the weekly average of daily pain assessed by patient self report
Change from pretreatment baseline in patient global assessment of OA
Change from pretreatment baseline in participant self-reported quality of life measured by SF-36
Response to PTP-001 on the OMERACT-OARSI responder criteria
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