Conversion to Embeda With Rescue Trial (ConvERT)

• Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase [ Time Frame: Baseline through Week 6 ] [ Designated as safety issue: No ]
  A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
  
  
• Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy [ Time Frame: Baseline through Week 6 ] [ Designated as safety issue: No ]
  A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
  
  

• Duration to Titrate Participants to Stable Dose [ Time Frame: Baseline through Week 6 ] [ Designated as safety issue: No ]
  A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
  
  
• Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy [ Time Frame: Baseline through Week 6 ] [ Designated as safety issue: No ]
  A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
  
  
• Number of Titration Steps to Achieve Stable Dose [ Time Frame: Baseline through Week 6 ] [ Designated as safety issue: No ]
  A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
  
  
• Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy [ Time Frame: Baseline through Week 6 ] [ Designated as safety issue: No ]
  A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
  
  
• Percentage of Participants With Rescue Medications Usage During Titration [ Time Frame: Baseline through Week 6 ] [ Designated as safety issue: No ]
  Rescue pain medications were used for supplemental analgesia for breakthrough pain during titration phase. Morphine sulfate IR tablet (less than 20 percent of the total daily dose of EMBEDA per IR dose), ibuprofen (up to 400 milligram (mg)/dose; not to exceed 1200 mg/day), and acetaminophen (up to 1000 mg/dose, not to exceed 4000 mg/day) were used as rescue medications.
  
  
• Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) [ Time Frame: Baseline, Visit 3 (up to Week 6) ] [ Designated as safety issue: No ]
  BPI is an 11-item self-report questionnaire: consist of 4 questions that assess pain intensity (worst, least, average, relief) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question answered on a scale range:0-10 (0%-100% for relief), '0=No pain/no relief/no interference and 10=Pain as bad as you can imagine/complete relief/ complete interference'.Measure can be scored by item, with lower scores being indicative of less pain or pain interference.
  
  
• Investigator's Level of Satisfaction With the EMBEDA Conversion Guide [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  The conversion assessment survey is a brief questionnaire using multiple choice options and numeric rating scale (NRS) with specified anchored responses ranging on a scale from 0-10 (0 = very dissatisfied, 5 = neutral, and 10=very satisfied) to assess the Investigator's level of satisfaction with the EMBEDA Conversion Guide.
  
  

• Number of Participants With Aberrant Behaviors [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  Current Opioid Misuse Measure (COMM) is a 17-item self-administered test used to monitor aberrant behavior in participants on opioid therapy. Aberrant behaviors assessed using a 5-point scale [0 = 'never' and 4 = 'very often']. Score range 0-68. Scores greater than or equal to 9 indicated the presence of aberrant behaviors.
  
  
• Number of Participants With Abnormal Urine Drug Test Results [ Time Frame: Baseline, Visit 3 (up to Week 6) ] [ Designated as safety issue: No ]
  Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy [3, 4-methylenedioxyamphetamine (MDMA)], cocaine, phencyclidine (PCP) and marijuana [tetrahydrocannabinol (THC)]. Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.
  
  
• Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids [ Time Frame: Visit 3 (up to Week 6) ] [ Designated as safety issue: No ]
  Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.
  
  
• Number of Participants With Urine Drug Test Results Positive for Illicit Substances [ Time Frame: Baseline, Visit 3 (up to Week 6) ] [ Designated as safety issue: No ]
  Urine samples collected were screened using immunoassay techniques for following types of drugs:opioids,barbiturates,benzodiazepines,amphetamines,ecstasy(3,4MDMA),cocaine,PCP,marijuana (THC).Quantitative, confirmatory urine drug testing performed for positive results using gas chromatography or high-pressure liquid chromatography for following analytes: morphine,oxycodone,oxymorphone,hydrocodone,hydromorphone,fentanyl,methadone,benzodiazepines,amphetamines,cocaine,THC,PCP,MDMA. Illicit substances were drugs of categories:marijuana (THC) metabolite,cocaine metabolite,PCP,amphetamine.
  
  
• Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid [ Time Frame: Baseline, Visit 3 (up to Week 6) ] [ Designated as safety issue: No ]
  Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.
  
  

The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011.