Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain

• The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase. [ Time Frame: Double-blind phase (14 days) ] [ Designated as safety issue: No ]

  Ineffective treatment was defined as:

  • Subject took >1 gram of acetaminophen in a 24-hour period, or
  • Subject required a change in transdermal patch (TDS) dose, or
  • Subject had difficulty in keeping the TDS on, or
  • Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).

  Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.

  
  

• Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]

  The time of ineffective treatment was calculated as the earliest of the following:

  • The date the subject first took >1 gram of acetaminophen,
  • The visit date when ineffective treatment was first determined, or
  • The date the last patch was removed.
  
  
• The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  Note: The total numbers of "Subjects w/ineffective treatment or who discont'd" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS.
  
  
• The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets). [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.
  
  

Buprenorphine is a synthetic opioid analgesic with over 25 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.