Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

• "Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase. [ Time Frame: Weeks 4, 8, and 12 of the double-blind phase ] [ Designated as safety issue: No ]
  The "average pain over the last 24 hours" score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12).
  
  

• The Mean Daily Number of Supplemental Analgesic Medication Tablets [ Time Frame: Double-blind phase (84 days) ] [ Designated as safety issue: No ]
  The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®.
  
  
• The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase [ Time Frame: Weeks 4, 8 and 12 of the double-blind phase ] [ Designated as safety issue: No ]

  The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete.

  The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst).

  
  
• The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase [ Time Frame: Weeks 4, 8, and 12 of the Double-blind Phase ] [ Designated as safety issue: No ]
  The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity of optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.
  
  

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.