Chronic Disease, Pain
Conditions
Keywords
chronic pain, Embeda, opioid, moderate pain, severe pain, conversion, converting, switching, morphine, aberrant behavior, Pain (DT) + Chronic Disease (DT)
Brief summary
The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion.
Detailed description
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.
Interventions
DRUGmorphine sulfate and naltrexone hydrochloride (EMBEDA)
Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be able to read, speak and understand English * Have chronic moderate to severe pain for at least 3 months * Require around the clock opioid medication for the relief of pain * Have been taking a daily opioid for at least 30 days prior to starting the study * Be able to be safely switched to a different pain medication * Be practicing acceptable birth control methods for female patients of childbearing potential * Be willing to participate in the study and able to comply with study procedures
Exclusion criteria
* Be currently diagnosed with or participating in and/or seeking treatment for opioid and/or alcohol abuse * Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids * Be currently taking tramadol and/or extended release morphine products * Have respiratory depression * Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease * Have migraines as your main source of pain * Have any form of bowel obstruction * Be pregnant or breast feeding * Have had 2 or more surgeries for low back pain * Be planning a major surgery during the study * Be staying in a hospital or nursing home * Be planning to have steroid injections for your chronic pain during the study * Have a life expectancy of less than 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase | Baseline through Week 6 | 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 | Baseline through Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Titration Steps to Achieve Stable Dose | Baseline through Week 6 | 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 | Baseline through Week 6 | 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 | Baseline through Week 6 | 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 | Baseline through Week 6 | 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) | Baseline, Visit 3 (up to Week 6) | 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 | Week 6 | 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. |
| Duration to Titrate Participants to Stable Dose | Baseline through Week 6 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Urine Drug Test Results Positive for Illicit Substances | Baseline, Visit 3 (up to Week 6) | 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 | Baseline, Visit 3 (up to Week 6) | 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 Unaccounted Opioids | Visit 3 (up to Week 6) | 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 Abnormal Urine Drug Test Results | Baseline, Visit 3 (up to Week 6) | 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 Aberrant Behaviors | Day 5 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EMBEDA EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks). | 684 |
| Total | 684 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Maintenance Phase (8 Weeks) | Adverse Event | 10 |
| Maintenance Phase (8 Weeks) | Lost to Follow-up | 9 |
| Maintenance Phase (8 Weeks) | Other | 66 |
| Maintenance Phase (8 Weeks) | Physician Decision | 3 |
| Maintenance Phase (8 Weeks) | Withdrawal by Subject | 29 |
| Titration Phase (up to 6 Weeks) | Adverse Event | 47 |
| Titration Phase (up to 6 Weeks) | Lost to Follow-up | 19 |
| Titration Phase (up to 6 Weeks) | Other | 62 |
| Titration Phase (up to 6 Weeks) | Participant did not reach stable dose | 13 |
| Titration Phase (up to 6 Weeks) | Physician Decision | 30 |
| Titration Phase (up to 6 Weeks) | Withdrawal by Subject | 162 |
Baseline characteristics
| Characteristic | EMBEDA |
|---|---|
| Age Continuous | 51.77 Years STANDARD_DEVIATION 12.34 |
| Brief Pain Inventory (BPI) Average Pain (n = 636) | 6.27 Units on a scale STANDARD_DEVIATION 1.79 |
| Brief Pain Inventory (BPI) Enjoyment of Life (n = 640) | 7.03 Units on a scale STANDARD_DEVIATION 2.64 |
| Brief Pain Inventory (BPI) General Activity (n = 643) | 7.01 Units on a scale STANDARD_DEVIATION 2.33 |
| Brief Pain Inventory (BPI) Least Pain (n = 642) | 4.63 Units on a scale STANDARD_DEVIATION 2.27 |
| Brief Pain Inventory (BPI) Mood (n = 642) | 6.31 Units on a scale STANDARD_DEVIATION 2.73 |
| Brief Pain Inventory (BPI) Normal Work (n = 637) | 7.21 Units on a scale STANDARD_DEVIATION 2.48 |
| Brief Pain Inventory (BPI) Relationships with Others (n = 644) | 5.41 Units on a scale STANDARD_DEVIATION 3.08 |
| Brief Pain Inventory (BPI) Relief (n = 639) | 53.36 Units on a scale STANDARD_DEVIATION 22.72 |
| Brief Pain Inventory (BPI) Sleep (n = 642) | 6.80 Units on a scale STANDARD_DEVIATION 2.74 |
| Brief Pain Inventory (BPI) Walking Ability (n = 641) | 6.48 Units on a scale STANDARD_DEVIATION 2.78 |
| Brief Pain Inventory (BPI) Worst Pain (n = 636) | 7.95 Units on a scale STANDARD_DEVIATION 1.64 |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Abuse: High(Ir)/ High(Pa) (n= 1) | 0 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Abuse: High(Ir)/ Low(Pa) (n= 1) | 0 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Abuse: High(Ir)/ Mod(Pa) (n= 1) | 1 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Abuse: Low(Ir)/ High(Pa) (n= 6) | 0 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Abuse: Low(Ir)/ Low(Pa) (n= 6) | 6 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Abuse: Low(Ir)/ Moderate (Mod)(Pa) (n= 6) | 0 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Abuse: Mod(Ir)/ High(Pa) (n= 1) | 0 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Abuse: Mod(Ir)/ Low(Pa) (n= 1) | 1 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Abuse: Mod(Ir)/ Mod(Pa) (n= 1) | 0 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Diversion: High (Ir)/ High (Pa) (n= 5) | 2 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Diversion: High (Ir)/ Low (Pa) (n= 5) | 3 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Diversion: High (Ir)/ Mod (Pa) (n= 5) | 0 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Diversion: Low (Ir)/ High (Pa) (n= 487) | 10 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Diversion: Low (Ir)/ Low (Pa) (n= 487) | 467 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Diversion: Low (Ir)/ Mod (Pa) (n= 487) | 10 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Diversion: Mod (Ir)/ High (Pa) (n= 22) | 1 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Diversion: Mod (Ir)/ Low (Pa) (n= 22) | 19 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Diversion: Mod (Ir)/ Mod (Pa) (n= 22) | 2 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse General: High(Ir)/ High(Pa) (n= 3) | 0 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse General: High(Ir)/ Low(Pa) (n= 3) | 2 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse General: High(Ir)/ Mod(Pa) (n= 3) | 1 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse General: Low(Ir)/ High(Pa) (n= 127) | 0 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse General: Low(Ir)/ Low(Pa) (n= 127) | 118 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse General: Low(Ir)/ Mod(Pa) (n= 127) | 9 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse General: Mod(Ir)/ High(Pa) (n= 24) | 0 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse General: Mod(Ir)/ Low(Pa) (n= 24) | 22 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse General: Mod(Ir)/ Mod(Pa) (n= 24) | 2 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Pseudoaddiction: High(Ir)/ High(Pa) (n= 5) | 1 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Pseudoaddiction: High(Ir)/ Low(Pa) (n= 5) | 3 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Pseudoaddiction: High(Ir)/ Mod(Pa) (n= 5) | 1 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Pseudoaddiction: Low(Ir)/ High(Pa) (n= 227) | 1 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Pseudoaddiction: Low(Ir)/ Low(Pa) (n= 227) | 208 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Pseudoaddiction: Low(Ir)/ Mod(Pa) (n= 227) | 18 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Pseudoaddiction: Mod(Ir)/ High(Pa) (n= 42) | 1 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Pseudoaddiction: Mod(Ir)/ Low(Pa) (n= 42) | 38 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Pseudoaddiction: Mod(Ir)/ Mod(Pa) (n= 42) | 3 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Total: High(Ir)/ High(Pa) (n= 6) | 1 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Total: High(Ir)/ Low(Pa) (n= 6) | 3 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Total: High(Ir)/ Mod(Pa) (n= 6) | 2 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Total: Low(Ir)/ High(Pa) (n= 295) | 1 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Total: Low(Ir)/ Low(Pa) (n= 295) | 245 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Total: Low(Ir)/ Mod(Pa) (n= 295) | 49 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Total: Mod(Ir)/ High(Pa) (n= 56) | 2 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Total: Mod(Ir)/ Low(Pa) (n= 56) | 40 Participants |
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion Misuse Total: Mod(Ir)/ Mod(Pa) (n= 56) | 14 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Alcohol(Alc)use when on Op:tried once/twice(n=534) | 32 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Alc use when on Op:daily(n=534) | 7 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Alc use when on Op:few times a month(n=534) | 35 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Alc use when on Op:few times a week(n=534) | 19 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Alc use when on Op:few times a year(n=534) | 50 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Alc use when on Op:never(n=534) | 391 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Chewed/crushed Op:daily(n=534) | 5 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Chewed/crushed Op:few times a month(n=534) | 10 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Chewed/crushed Op:few times a week(n=534) | 7 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Chewed/crushed Op:few times a year(n=534) | 5 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Chewed/crushed Op:never(n=534) | 476 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Chewed/crushed Op:tried once/twice(n=534) | 31 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Gave Op to sick/in pain:no(n=526) | 491 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Gave Op to sick/in pain:yes, >10 times(n=35) | 3 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Gave Op to sick/in pain:yes, 2-5times(n=35) | 24 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Gave Op to sick/in pain:yes,6-10times(n=35) | 3 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Gave Op to sick/in pain:yes (n=526) | 35 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Gave Op to sick/in pain:yes,once(n=35) | 5 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Got Op from someone other than a doctor:no(n=537) | 494 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Got Op from someone other than a doctor:yes(n=537) | 43 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Keeps Op hidden or locked:no(n=535) | 162 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Keeps Op hidden or locked:yes(n=535) | 373 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion More Op than prescribed:daily(n=530) | 23 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion More Op than prescribed:few times a month(n=530) | 116 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion More Op than prescribed:few times a week(n=530) | 58 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion More Op than prescribed:few times a year(n=530) | 46 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion More Op than prescribed:never(n=530) | 212 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion More Op than prescribed:tried once/twice(n=530) | 75 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion More than 1 doctor (Dr) for Op:once/twice(n=529) | 26 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion More than 1 Dr for Op:never(n=529) | 488 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion More than 1 Dr for Op:often(n=529) | 3 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion More than 1 Dr for Op:sometime(n=529) | 12 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Reason(Rn)to chew/crush Op:treat pain better(n=71) | 35 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-Alc when on Op:enjoy occasional drink(n=170 | 91 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-Alc when on Op:feel less depressed(n=170) | 4 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-Alc when on Op:feel pleasant/high(n=170) | 3 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-Alc when on Op:feel talkative/outgoing(n=170) | 2 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-Alc when on Op:other(n=170) | 65 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-Alc when on Op:sleep better/relax(n=170) | 21 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-Alc when on Op:treat new pain(n=170) | 1 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-Alc when on Op:treat pain better(n=170) | 10 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn for more Op use:feel less depressed (n=315) | 16 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn for more Op use:feel pleasant/high(n=315) | 3 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn for more Op use:feel talkative/outgoing(n=315) | 3 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn for more Op use: other(n=315) | 44 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn for more Op use:sleep better/relax(n=315) | 48 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn for more Op use:treat new pain(n=315) | 42 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn for more Op use:treat pain better(n=315) | 274 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn- more than 1 Dr:afraid to ask for more(n=61) | 12 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn- more than 1 Dr:Dr didn't prescribed more(n=61) | 11 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn- more than 1 Dr:feel pleasant/high (n=61) | 1 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn- more than (>) 1 Dr:other(n=61) | 24 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn- more than 1 Dr: prevent withdrawal(n=61) | 6 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn- more than 1 Dr:treat pain better(n=61) | 26 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-snort,smoke,inj:feel less depressed (n=37) | 2 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-snort,smoke,inj:feel pleasant/high(n=37) | 2 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-snort,smoke,inj:feel talkative/outgoing(n=37) | 2 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-snort,smoke,inj:other(n=37) | 28 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-snort,smoke,inj:sleep better/relax(n=37) | 2 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-snort,smoke,inj:treat new pain (n=37) | 1 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn-snort,smoke,inj:treat pain better(n=37) | 10 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn to chew/crush Op:feel less depressed (n=71) | 6 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn to chew/crush Op:feel pleasant/high(n=71) | 3 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn to chew/crush Op:feel talkative/outgoing(n=71) | 2 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn to chew/crush Op:help swallow drug(n=71) | 16 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn to chew/crush Op:other(n=71) | 29 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn to chew/crush Op:sleep better/relax(n=71) | 14 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Rn to chew/crush Op:treat new pain(n=71) | 4 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Snort,smoke,inject(inj) Op:once/twice(n=533) | 7 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Snort,smoke,inj Op:daily(n=533) | 1 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Snort,smoke,inj Op:few times a month(n=533) | 2 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Snort,smoke,inj Op:few times a week(n=533) | 0 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Snort,smoke,inj Op: few times a year(n=533) | 0 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Snort,smoke,inj Op:never(n=533) | 523 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Suspected someone taking Op:no(n=535) | 464 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Suspected someone taking Op:yes,all times (n=70) | 3 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Suspected someone taking Op:yes,few times(n=70) | 29 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Suspected someone taking Op:yes(n=535) | 71 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Suspected someone taking Op:yes,once(n=70) | 30 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Suspected someone taking Op:yes,sometimes (n=70) | 8 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried about hard time to stop Op:0(n=537) | 138 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried about hard time to stop Op:10(n=537) | 36 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried about hard time to stop Op:1(n=537) | 50 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried about hard time to stop Op:2(n=537) | 67 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried about hard time to stop Op:3(n=537) | 45 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried about hard time to stop Op:4(n=537) | 20 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried about hard time to stop Op:5(n=537) | 54 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried about hard time to stop Op:6(n=537) | 26 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried about hard time to stop Op:7(n=537) | 39 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried about hard time to stop Op:8(n=537) | 35 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried about hard time to stop Op:9(n=537) | 27 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried getting addicted or hooked to Op:0(n=537) | 171 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried getting addicted or hooked to Op:10(n=537) | 33 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried getting addicted or hooked to Op:1(n=537) | 47 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried getting addicted or hooked to Op:2(n=537) | 53 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried getting addicted or hooked to Op:3(n=537) | 47 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried getting addicted or hooked to Op:4(n=537) | 30 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried getting addicted or hooked to Op:5(n=537) | 53 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried getting addicted or hooked to Op:6(n=537) | 28 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried getting addicted or hooked to Op:7(n=537) | 33 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried getting addicted or hooked to Op:8(n=537) | 31 Participants |
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion Worried getting addicted or hooked to Op:9(n=537) | 11 Participants |
| Sex: Female, Male Female | 378 Participants |
| Sex: Female, Male Male | 306 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 331 / 684 |
| serious Total, serious adverse events | 24 / 684 |
Outcome results
Primary
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase
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.
Time frame: Baseline through Week 6
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMBEDA | Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase | 51.3 Percentage of participants |
Primary
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
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.
Time frame: Baseline through Week 6
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Participants were stratified based on prior opioid therapy. The 'n' is signifying those participants who were evaluated for this measure for each of the prior medication received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EMBEDA | Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy | Transdermal Fentanyl (n= 77) | 54.5 Percentage of participants |
| EMBEDA | Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy | Immediate-release (IR) Hydrocodone (n= 164) | 60.4 Percentage of participants |
| EMBEDA | Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy | IR Hydromorphone (n= 22) | 63.6 Percentage of participants |
| EMBEDA | Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy | IR Oxycodone (n= 160) | 48.1 Percentage of participants |
| EMBEDA | Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy | IR Morphine (n= 53) | 62.3 Percentage of participants |
| EMBEDA | Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy | Methadone (n= 64) | 40.6 Percentage of participants |
| EMBEDA | Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy | Extended-release (ER) Oxycodone (n= 107) | 42.1 Percentage of participants |
| EMBEDA | Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy | ER Oxymorphone (n= 25) | 56.0 Percentage of participants |
| EMBEDA | Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy | Excluded Opioid/ Unclassified (n= 12) | 8.3 Percentage of participants |
Secondary
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
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.
Time frame: Baseline, Visit 3 (up to Week 6)
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for the respective subscale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EMBEDA | Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) | Change at Visit 3 (Average Pain) (n=313) | -2.23 Units on a scale | Standard Deviation 2.13 |
| EMBEDA | Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) | Change at Visit 3 (Worst Pain) (n=313) | -2.41 Units on a scale | Standard Deviation 2.49 |
| EMBEDA | Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) | Change at Visit 3 (Least Pain) (n=321) | -1.81 Units on a scale | Standard Deviation 2.33 |
| EMBEDA | Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) | Change at Visit 3 (Relief) (n=0) | NA Units on a scale | — |
| EMBEDA | Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) | Change at Visit 3 (General Activity) (n=0) | NA Units on a scale | — |
| EMBEDA | Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) | Change at Visit 3 (Mood) (n=0) | NA Units on a scale | — |
| EMBEDA | Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) | Change at Visit 3 (Walking Ability) (n=0) | NA Units on a scale | — |
| EMBEDA | Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) | Change at Visit 3 (Normal Work) (n=0) | NA Units on a scale | — |
| EMBEDA | Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) | Change at Visit 3(Relationships with Others) (n=0) | NA Units on a scale | — |
| EMBEDA | Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) | Change at Visit 3 (Sleep) (n=0) | NA Units on a scale | — |
| EMBEDA | Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) | Change at Visit 3 (Enjoyment of Life) (n=0) | NA Units on a scale | — |
Secondary
Duration to Titrate Participants to Stable Dose
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.
Time frame: Baseline through Week 6
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMBEDA | Duration to Titrate Participants to Stable Dose | 20.0 Days | Standard Deviation 8.94 |
Secondary
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
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.
Time frame: Baseline through Week 6
Population: Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EMBEDA | Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy | Methadone (n= 26) | 21.0 Days | Standard Deviation 8.7 |
| EMBEDA | Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy | Transdermal Fentanyl (n= 42) | 17.8 Days | Standard Deviation 5.96 |
| EMBEDA | Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy | IR Hydrocodone (n= 99) | 20.7 Days | Standard Deviation 9.13 |
| EMBEDA | Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy | IR Hydromorphone (n= 14) | 24.3 Days | Standard Deviation 12.55 |
| EMBEDA | Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy | IR Oxycodone (n= 77) | 19.6 Days | Standard Deviation 8.35 |
| EMBEDA | Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy | IR Morphine (n= 33) | 18.8 Days | Standard Deviation 7.82 |
| EMBEDA | Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy | ER Oxycodone (n= 45) | 20.3 Days | Standard Deviation 10.55 |
| EMBEDA | Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy | ER Oxymorphone (n= 14) | 19.8 Days | Standard Deviation 10.71 |
| EMBEDA | Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy | Excluded Opioid/ Unclassified (n= 1) | 7.0 Days | — |
Secondary
Investigator's Level of Satisfaction With the EMBEDA Conversion Guide
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.
Time frame: Week 6
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMBEDA | Investigator's Level of Satisfaction With the EMBEDA Conversion Guide | 8.1 Units on a Scale | Standard Deviation 2.11 |
Secondary
Number of Titration Steps to Achieve Stable Dose
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.
Time frame: Baseline through Week 6
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMBEDA | Number of Titration Steps to Achieve Stable Dose | 2.4 titration steps | Standard Deviation 1.37 |
Secondary
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
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.
Time frame: Baseline through Week 6
Population: Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EMBEDA | Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy | Transdermal Fentanyl (n= 42) | 2.0 titration steps | Standard Deviation 0.98 |
| EMBEDA | Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy | IR Hydrocodone (n= 99) | 2.6 titration steps | Standard Deviation 1.41 |
| EMBEDA | Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy | IR Hydromorphone (n= 14) | 2.6 titration steps | Standard Deviation 1.28 |
| EMBEDA | Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy | IR Oxycodone (n= 77) | 2.3 titration steps | Standard Deviation 1.4 |
| EMBEDA | Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy | IR Morphine (n= 33) | 2.3 titration steps | Standard Deviation 1.28 |
| EMBEDA | Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy | Methadone (n= 26) | 2.7 titration steps | Standard Deviation 1.52 |
| EMBEDA | Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy | ER Oxycodone (n= 45) | 2.4 titration steps | Standard Deviation 1.5 |
| EMBEDA | Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy | ER Oxymorphone (n= 14) | 2.5 titration steps | Standard Deviation 1.45 |
| EMBEDA | Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy | Excluded Opioid/ Unclassified (n= 1) | 1.0 titration steps | — |
Secondary
Percentage of Participants With Rescue Medications Usage During Titration
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.
Time frame: Baseline through Week 6
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMBEDA | Percentage of Participants With Rescue Medications Usage During Titration | 79.8 Percentage of participants |
Other Pre-specified
Number of Participants With Aberrant Behaviors
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.
Time frame: Day 5
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMBEDA | Number of Participants With Aberrant Behaviors | 217 Participants |
Other Pre-specified
Number of Participants With Abnormal Urine Drug Test Results
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.
Time frame: Baseline, Visit 3 (up to Week 6)
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EMBEDA | Number of Participants With Abnormal Urine Drug Test Results | Baseline (n= 684) | 160 Participants |
| EMBEDA | Number of Participants With Abnormal Urine Drug Test Results | Visit 3 (n= 351) | 101 Participants |
Other Pre-specified
Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid
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.
Time frame: Baseline, Visit 3 (up to Week 6)
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EMBEDA | Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid | Baseline (n= 684) | 122 Participants |
| EMBEDA | Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid | Visit 3 (n= 351) | 11 Participants |
Other Pre-specified
Number of Participants With Urine Drug Test Results Positive for Illicit Substances
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.
Time frame: Baseline, Visit 3 (up to Week 6)
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EMBEDA | Number of Participants With Urine Drug Test Results Positive for Illicit Substances | Baseline (n= 684) | 51 Participants |
| EMBEDA | Number of Participants With Urine Drug Test Results Positive for Illicit Substances | Visit 3 (n= 351) | 24 Participants |
Other Pre-specified
Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids
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.
Time frame: Visit 3 (up to Week 6)
Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMBEDA | Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids | 85 Participants |