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Diacerein vs Celecoxib in Knee Osteoarthritis
NCT02688400Phase 3
Key facts
- Status
- Completed
- Start
- May 2016
- Primary completion
- Jun 2018
- Countries
- 5
- Sponsor
- TRB Chemedica
- Modality
- DNA Intercalators/Alkylators
- Drugs
- diacerein
- Conditions
- osteoarthritis (OA)
01
Overview
Phase 3, randomised, double-blind trial of diacerein in osteoarthritis (OA) (2 arms), sponsored by TRB Chemedica. Primary endpoint: Change From Baseline in WOMAC A Pain Subscale at 182 days. Started May 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Diacerein
Diacerein 50mg (1/day for 1 month, then 2/day) + Placebo
Celecoxib
Celecoxib 200mg (1/day) + Placebo
03
Who it enrols
Patients >= 50 years with primary knee OA (Kellgren-Lawrence 2-3), joint space width >= 2mm, and moderate-to-severe pain (VAS >= 40mm). Excludes secondary OA, significant comorbidities (heart, liver, kidney, GI), and recent use of corticosteroids or other OA treatments.
04
Endpoints
Primary
Change From Baseline in WOMAC A Pain Subscale
Secondary
Change From Baseline in WOMAC OA Scores
Absolute Changes From Baseline in Pain Visual Analogue Scale
OARSI Responders
Assessment of Joint Swelling, Effusion or Both
Consumption of Acetaminophen
Change From Baseline in Patient's Global Assessment of Disease Activity
Global Assessment of Response to Therapy
Quality of Life SF-36
05
Results
Primary endpoints met
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