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Conversion to Embeda With Rescue Trial (ConvERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01179191
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : August 11, 2010
Results First Posted : September 5, 2012
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Disease Pain Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA) Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 684 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Multi-Center, Primary Care-Based, Open-Label Study to Assess the Success of Converting Opioid-Experienced Patients, With Chronic, Moderate to Severe Pain, to EMBEDA Using a Standardized Conversion Guide, and to Identify Behaviors Related to Prescription Opioid Abuse, Misuse, and Diversion
Study Start Date : August 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: morphine sulfate and naltrexone hydrochloride (EMBEDA) Drug: morphine 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase [ Time Frame: 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.

  2. Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy [ Time Frame: 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 Outcome Measures :
  1. Duration to Titrate Participants to Stable Dose [ Time Frame: 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.

  2. Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy [ Time Frame: 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.

  3. Number of Titration Steps to Achieve Stable Dose [ Time Frame: 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.

  4. Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy [ Time Frame: 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.

  5. Percentage of Participants With Rescue Medications Usage During Titration [ Time Frame: 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.

  6. 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) ]
    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.

  7. Investigator's Level of Satisfaction With the EMBEDA Conversion Guide [ Time Frame: 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.


Other Outcome Measures:
  1. Number of Participants With Aberrant Behaviors [ Time Frame: 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.

  2. Number of Participants With Abnormal Urine Drug Test Results [ Time Frame: 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.

  3. Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids [ Time Frame: 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.

  4. Number of Participants With Urine Drug Test Results Positive for Illicit Substances [ Time Frame: 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.

  5. 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) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179191


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01179191    
Other Study ID Numbers: ALO-01-10-4003
B4541001
First Posted: August 11, 2010    Key Record Dates
Results First Posted: September 5, 2012
Last Update Posted: October 11, 2012
Last Verified: October 2012
Keywords provided by Pfizer:
chronic pain
Embeda
opioid
moderate pain
severe pain
conversion
 converting
switching
morphine
aberrant behavior
Pain (DT) + Chronic Disease (DT)
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes
Naltrexone
Morphine
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents
Narcotic Antagonists