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osteoarthritis - ARCOXIA vs Diclofenac - results

Results   Design Patient Characteristics     Tolerability

ARCOXIA and diclofenac compared in double-blind, randomized, multicenter, active-comparator–controlled, international trial in more than 500 patients4

Entry Criteria
  • Osteoarthritis (OA) of the knee or hip confirmed by clinical and radiographic criteria and pain flare after 3- to 20-day washout of prestudy nonsteroidal anti-inflammatory drugs (NSAIDs)

Treatments

  • ARCOXIA 60 mg once daily or
  • Diclofenac 50 mg three times daily
Treatment Duration
  • 6 weeks
Primary Efficacy Endpoint
  • Western Ontario and McMaster Universities (WOMAC) Pain Subscale—OA pain over previous 48 hours while walking on a flat surface, going up or down stairs, at night while in bed, sitting or lying, and standing upright rated by patient on visual analog scale (VAS) of 0 (no pain) to 100 (extreme pain) mm
  • Primary endpoint measured at weeks 2, 4, and 6
Secondary Efficacy Endpoints
  • WOMAC stiffness subscale—severity of stiffness after first awakening in the morning and after sitting, lying, or resting later in the day rated on a VAS from 0 (no stiffness) to 100 (extreme stiffness) mm
  • WOMAC physical function subscale—degree of difficulty in past 48 hours with 17 everyday situations reflecting mobility and ability to perform activities of daily living rated on VAS from 0 (no difficulty) to 100 (extreme difficulty) mm
  • Patient Global Assessment of Response to Therapy (PGART) rated as excellent (0), good (1), fair (2), poor (3), or none (4)
  • Secondary endpoints measured at weeks 2, 4, and 6
Other Endpoints
  • Early efficacy assessed by first question of WOMAC OA Index (pain walking on a flat surface) and PGART, each recorded at 4 hours after the first (morning) dose of study medication on days 1 and 2
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