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Efficacy and Safety of YYC301 in Knee Osteoarthritis
NCT03850587Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2018
- Primary completion
- May 2020
- Countries
- 1
- Sponsor
- Yooyoung Pharmaceutical
- Modality
- Small Molecules
- Drugs
- tramadol + celecoxib
- Conditions
- knee osteoarthritis (OA)
01
Overview
Phase 2, randomised, double-blind trial of tramadol + celecoxib in knee osteoarthritis (OA) (4 arms), sponsored by Yooyoung Pharmaceutical. Primary endpoints: 100mm Pain Visual Analog Scale at 12 weeks, Knee Injury and Osteoarthritis Outcome Score at 12 weeks and 2 more. Started Aug 2018; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
YYC301-1 (Tramadol 37.5mg + Celecoxib 200mg)
Experimental Arm: Low dose Tramadol combo
YYC301-2 (Tramadol 75mg + Celecoxib 200mg)
Experimental Arm: Medium dose Tramadol combo
YYC301-3 (Tramadol 150mg + Celecoxib 200mg)
Experimental Arm: High dose Tramadol combo
Celecoxib 200mg
Active Comparator Arm
03
Who it enrols
Adults with knee osteoarthritis and persistent pain despite Celecoxib treatment.
04
Endpoints
Primary
100mm Pain Visual Analog Scale
Knee Injury and Osteoarthritis Outcome Score
Patient Global Assessment
Total dosage and dosage rate of rescue treatment
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