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Duloxetine in Japanese patients with knee osteoarthritis
NCT02248480Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2014
- Primary completion
- Jun 2015
- Countries
- 1
- Sponsor
- Eli Lilly and Company
- Modality
- Small Molecules
- Drugs
- duloxetine
- Conditions
- osteoarthritis (OA)
01
Overview
Phase 3, randomised, double-blind trial in osteoarthritis (OA) comparing Duloxetine with Placebo (2 arms). Primary endpoint: Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score at 14 weeks. Started Oct 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Duloxetine
Duloxetine 60 mg QD (titrated)
Placebo
Placebo QD
03
Who it enrols
Japanese patients with chronic osteoarthritis of the knee and moderate to severe pain (BPI score >= 4), without major depressive disorder or other significant psychiatric/medical conditions.
04
Endpoints
Primary
Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score
Secondary
Change From Baseline in Patient Global Impression of Improvement
Change From Baseline on the Clinical Global Impression of Severity
Change From Baseline on the 36-Item Short-Form Health Survey
Change From Baseline on the Beck Depression Inventory Total Score
Percentage of Participants With Fall Events From Fall Questionnaire
Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index Questionnaire Total Score
Change From Baseline on the Patient Global Assessment Illness Score
Change From Baseline on the 5 Dimension Version of the European Quality of Life Instrument
05
Results
Primary endpoints met
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