• Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) [ Time Frame: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. ] [ Designated as safety issue: No ]
  Subjects were asked, "Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit." 0 = no pain and 10 = pain as bad as you can imagine it.
  
  
• Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF) [ Time Frame: Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. ] [ Designated as safety issue: No ]
  Subjects were asked, "Please rate your pain by circling the one number (0-10) that tells how much pain you have right now." Subjects rated their answers on a 0-10 ordinal scale from 0 = "No pain" to 10 = "Pain as bad as you can imagine it." Pain right now is presented as the LSmean [change from baseline] (SE).
  
  

• "Physical Functioning" Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF) [ Time Frame: Day 84, or, if applicable, at early termination ] [ Designated as safety issue: No ]
  The Medical Outcomes Survey (MOS) Short-Form-36 Health Survey (SF-36) assesses 8 categories of functionality through 36 individual questions. "Physical Functioning" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
  
  
• "Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  The Medical Outcomes Survey Short-Form-36 health survey assesses 8 categories of functionality through 36 individual questions. "Physical Role" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
  
  
• "Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Bodily Pain" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
  
  
• "General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "General Health" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at clinic. The mean scores were analyzed.
  
  
• "Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Vitality" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
  
  
• "Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Social Functioning" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
  
  
• "Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Emotional Role" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
  
  
• "Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Mental Health" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
  
  
• Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  The therapeutic response was rated by the investigator. The assessment was completed by the investigator using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
  
  
• Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  The therapeutic response was rated by the subject. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
  
  
• Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  The subject compared study drug treatment to prestudy analgesic. The assessment was completed by the subject using a 0-2 ordinal scale from 0 = "Worse than prestudy medicine" to 2 = "Better than prestudy medicine."
  
  
• Subject Satisfaction: Mean ± SEM (Day 84)(LOCF) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  The subject assessed satisfaction with study drug. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
  
  
• Time to Stable Pain Management [ Time Frame: Start of study to day 21. ] [ Designated as safety issue: No ]
  For each subject, "time to stable pain management" is defined as the first (post-baseline) time during the titration period when his/her "diary pain" was 4 or less (or at least 2 points lower than baseline) for 3 consecutive daily records or the "pain on the average" (at the day 7 or day 21 visit) was 4 or less (or at least 2 points lower than baseline).
  
  
• The Time to Discontinuation Due to Lack of Efficacy [ Time Frame: Time after dosing to dropout due to lack of efficacy ] [ Designated as safety issue: No ]
  Dropouts due to various reasons were summarized by counts and percentage. Cox proportional hazards regression was used to assess the treatment differences in time to dropout due to lack of efficacy. Clinically important covariates (including gender, age, race, weight, baseline pain, and previous opioid use) were incorporated into the model when statistically significant at P< .10, using a backward elimination procedure.
  
  

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.