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Conversion to Embeda With Rescue Trial (ConvERT)

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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Chronic Disease
Pain
Intervention Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Enrollment 684
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EMBEDA
Hide Arm/Group Description 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).
Period Title: Titration Phase (up to 6 Weeks)
Started 684
Completed 351
Not Completed 333
Reason Not Completed
Adverse Event             47
Lost to Follow-up             19
Physician Decision             30
Withdrawal by Subject             162
Participant did not reach stable dose             13
Other             62
Period Title: Maintenance Phase (8 Weeks)
Started 351
Completed 234
Not Completed 117
Reason Not Completed
Adverse Event             10
Lost to Follow-up             9
Physician Decision             3
Withdrawal by Subject             29
Other             66
Arm/Group Title EMBEDA
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 684
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 684 participants
51.77  (12.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 684 participants
Female
378
  55.3%
Male
306
  44.7%
Brief Pain Inventory (BPI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 684 participants
Average Pain (n = 636) 6.27  (1.79)
Worst Pain (n = 636) 7.95  (1.64)
Least Pain (n = 642) 4.63  (2.27)
Relief (n = 639) 53.36  (22.72)
General Activity (n = 643) 7.01  (2.33)
Mood (n = 642) 6.31  (2.73)
Walking Ability (n = 641) 6.48  (2.78)
Normal Work (n = 637) 7.21  (2.48)
Relationships with Others (n = 644) 5.41  (3.08)
Sleep (n = 642) 6.80  (2.74)
Enjoyment of Life (n = 640) 7.03  (2.64)
[1]
Measure Description: BPI:11-item questionnaire,4 questions:pain intensity(worst,least,average,relief),7questions:pain impact on daily functions(general activity,mood,walking ability,normal work,relations with others,sleep,life enjoyment).Each question range=0-10(0%-100% for relief),higher score=more pain/relief/interference.'n'=participants evaluated for each subscale.
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 684 participants
Abuse: Low(Ir)/ Low(Pa) (n= 6) 6
Abuse: Low(Ir)/ Moderate (Mod)(Pa) (n= 6) 0
Abuse: Low(Ir)/ High(Pa) (n= 6) 0
Abuse: Mod(Ir)/ Low(Pa) (n= 1) 1
Abuse: Mod(Ir)/ Mod(Pa) (n= 1) 0
Abuse: Mod(Ir)/ High(Pa) (n= 1) 0
Abuse: High(Ir)/ Low(Pa) (n= 1) 0
Abuse: High(Ir)/ Mod(Pa) (n= 1) 1
Abuse: High(Ir)/ High(Pa) (n= 1) 0
Misuse General: Low(Ir)/ Low(Pa) (n= 127) 118
Misuse General: Low(Ir)/ Mod(Pa) (n= 127) 9
Misuse General: Low(Ir)/ High(Pa) (n= 127) 0
Misuse General: Mod(Ir)/ Low(Pa) (n= 24) 22
Misuse General: Mod(Ir)/ Mod(Pa) (n= 24) 2
Misuse General: Mod(Ir)/ High(Pa) (n= 24) 0
Misuse General: High(Ir)/ Low(Pa) (n= 3) 2
Misuse General: High(Ir)/ Mod(Pa) (n= 3) 1
Misuse General: High(Ir)/ High(Pa) (n= 3) 0
Misuse Pseudoaddiction: Low(Ir)/ Low(Pa) (n= 227) 208
Misuse Pseudoaddiction: Low(Ir)/ Mod(Pa) (n= 227) 18
Misuse Pseudoaddiction: Low(Ir)/ High(Pa) (n= 227) 1
Misuse Pseudoaddiction: Mod(Ir)/ Low(Pa) (n= 42) 38
Misuse Pseudoaddiction: Mod(Ir)/ Mod(Pa) (n= 42) 3
Misuse Pseudoaddiction: Mod(Ir)/ High(Pa) (n= 42) 1
Misuse Pseudoaddiction: High(Ir)/ Low(Pa) (n= 5) 3
Misuse Pseudoaddiction: High(Ir)/ Mod(Pa) (n= 5) 1
Misuse Pseudoaddiction: High(Ir)/ High(Pa) (n= 5) 1
Misuse Total: Low(Ir)/ Low(Pa) (n= 295) 245
Misuse Total: Low(Ir)/ Mod(Pa) (n= 295) 49
Misuse Total: Low(Ir)/ High(Pa) (n= 295) 1
Misuse Total: Mod(Ir)/ Low(Pa) (n= 56) 40
Misuse Total: Mod(Ir)/ Mod(Pa) (n= 56) 14
Misuse Total: Mod(Ir)/ High(Pa) (n= 56) 2
Misuse Total: High(Ir)/ Low(Pa) (n= 6) 3
Misuse Total: High(Ir)/ Mod(Pa) (n= 6) 2
Misuse Total: High(Ir)/ High(Pa) (n= 6) 1
Diversion: Low (Ir)/ Low (Pa) (n= 487) 467
Diversion: Low (Ir)/ Mod (Pa) (n= 487) 10
Diversion: Low (Ir)/ High (Pa) (n= 487) 10
Diversion: Mod (Ir)/ Low (Pa) (n= 22) 19
Diversion: Mod (Ir)/ Mod (Pa) (n= 22) 2
Diversion: Mod (Ir)/ High (Pa) (n= 22) 1
Diversion: High (Ir)/ Low (Pa) (n= 5) 3
Diversion: High (Ir)/ Mod (Pa) (n= 5) 0
Diversion: High (Ir)/ High (Pa) (n= 5) 2
[1]
Measure Description: Number of participants at Ir-assessed risk level compared to Pa-derived risk level (low,moderate[mod] or high) for opioid misuse,abuse,diversion. An exploratory scoring algorithm applied to results of Participant's Experience and Concerns Questionnaire to get Pa-derived risk levels. Pa evaluable=683. 'n'=Pa evaluated for each assessed risk level.
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 684 participants
Worried getting addicted or hooked to Op:0(n=537) 171
Worried getting addicted or hooked to Op:1(n=537) 47
Worried getting addicted or hooked to Op:2(n=537) 53
Worried getting addicted or hooked to Op:3(n=537) 47
Worried getting addicted or hooked to Op:4(n=537) 30
Worried getting addicted or hooked to Op:5(n=537) 53
Worried getting addicted or hooked to Op:6(n=537) 28
Worried getting addicted or hooked to Op:7(n=537) 33
Worried getting addicted or hooked to Op:8(n=537) 31
Worried getting addicted or hooked to Op:9(n=537) 11
Worried getting addicted or hooked to Op:10(n=537) 33
Worried about hard time to stop Op:0(n=537) 138
Worried about hard time to stop Op:1(n=537) 50
Worried about hard time to stop Op:2(n=537) 67
Worried about hard time to stop Op:3(n=537) 45
Worried about hard time to stop Op:4(n=537) 20
Worried about hard time to stop Op:5(n=537) 54
Worried about hard time to stop Op:6(n=537) 26
Worried about hard time to stop Op:7(n=537) 39
Worried about hard time to stop Op:8(n=537) 35
Worried about hard time to stop Op:9(n=537) 27
Worried about hard time to stop Op:10(n=537) 36
Chewed/crushed Op:tried once/twice(n=534) 31
Chewed/crushed Op:few times a year(n=534) 5
Chewed/crushed Op:few times a month(n=534) 10
Chewed/crushed Op:few times a week(n=534) 7
Chewed/crushed Op:daily(n=534) 5
Chewed/crushed Op:never(n=534) 476
Reason(Rn)to chew/crush Op:treat pain better(n=71) 35
Rn to chew/crush Op:treat new pain(n=71) 4
Rn to chew/crush Op:sleep better/relax(n=71) 14
Rn to chew/crush Op:help swallow drug(n=71) 16
Rn to chew/crush Op:feel pleasant/high(n=71) 3
Rn to chew/crush Op:feel less depressed (n=71) 6
Rn to chew/crush Op:feel talkative/outgoing(n=71) 2
Rn to chew/crush Op:other(n=71) 29
More Op than prescribed:tried once/twice(n=530) 75
More Op than prescribed:few times a year(n=530) 46
More Op than prescribed:few times a month(n=530) 116
More Op than prescribed:few times a week(n=530) 58
More Op than prescribed:daily(n=530) 23
More Op than prescribed:never(n=530) 212
Rn for more Op use:treat pain better(n=315) 274
Rn for more Op use:treat new pain(n=315) 42
Rn for more Op use:sleep better/relax(n=315) 48
Rn for more Op use:feel pleasant/high(n=315) 3
Rn for more Op use:feel less depressed (n=315) 16
Rn for more Op use:feel talkative/outgoing(n=315) 3
Rn for more Op use: other(n=315) 44
Snort,smoke,inject(inj) Op:once/twice(n=533) 7
Snort,smoke,inj Op: few times a year(n=533) 0
Snort,smoke,inj Op:few times a month(n=533) 2
Snort,smoke,inj Op:few times a week(n=533) 0
Snort,smoke,inj Op:daily(n=533) 1
Snort,smoke,inj Op:never(n=533) 523
Rn-snort,smoke,inj:treat pain better(n=37) 10
Rn-snort,smoke,inj:treat new pain (n=37) 1
Rn-snort,smoke,inj:sleep better/relax(n=37) 2
Rn-snort,smoke,inj:feel pleasant/high(n=37) 2
Rn-snort,smoke,inj:feel less depressed (n=37) 2
Rn-snort,smoke,inj:feel talkative/outgoing(n=37) 2
Rn-snort,smoke,inj:other(n=37) 28
Alcohol(Alc)use when on Op:tried once/twice(n=534) 32
Alc use when on Op:few times a year(n=534) 50
Alc use when on Op:few times a month(n=534) 35
Alc use when on Op:few times a week(n=534) 19
Alc use when on Op:daily(n=534) 7
Alc use when on Op:never(n=534) 391
Rn-Alc when on Op:treat pain better(n=170) 10
Rn-Alc when on Op:treat new pain(n=170) 1
Rn-Alc when on Op:sleep better/relax(n=170) 21
Rn-Alc when on Op:enjoy occasional drink(n=170 91
Rn-Alc when on Op:feel pleasant/high(n=170) 3
Rn-Alc when on Op:feel less depressed(n=170) 4
Rn-Alc when on Op:feel talkative/outgoing(n=170) 2
Rn-Alc when on Op:other(n=170) 65
More than 1 doctor (Dr) for Op:once/twice(n=529) 26
More than 1 Dr for Op:sometime(n=529) 12
More than 1 Dr for Op:often(n=529) 3
More than 1 Dr for Op:never(n=529) 488
Rn- more than 1 Dr:treat pain better(n=61) 26
Rn- more than 1 Dr: prevent withdrawal(n=61) 6
Rn- more than 1 Dr:afraid to ask for more(n=61) 12
Rn- more than 1 Dr:feel pleasant/high (n=61) 1
Rn- more than 1 Dr:Dr didn't prescribed more(n=61) 11
Rn- more than (>) 1 Dr:other(n=61) 24
Gave Op to sick/in pain:yes (n=526) 35
Gave Op to sick/in pain:yes,once(n=35) 5
Gave Op to sick/in pain:yes, 2-5times(n=35) 24
Gave Op to sick/in pain:yes,6-10times(n=35) 3
Gave Op to sick/in pain:yes, >10 times(n=35) 3
Gave Op to sick/in pain:no(n=526) 491
Got Op from someone other than a doctor:yes(n=537) 43
Got Op from someone other than a doctor:no(n=537) 494
Keeps Op hidden or locked:yes(n=535) 373
Keeps Op hidden or locked:no(n=535) 162
Suspected someone taking Op:yes(n=535) 71
Suspected someone taking Op:yes,once(n=70) 30
Suspected someone taking Op:yes,few times(n=70) 29
Suspected someone taking Op:yes,sometimes (n=70) 8
Suspected someone taking Op:yes,all times (n=70) 3
Suspected someone taking Op:no(n=535) 464
[1]
Measure Description: Participant experience and concerns with prescription opioids questionnaire consisted of multiple choice questions and numeric rating scale(NRS);range=0(not at all) to 10 (extremely worried);used to assess current concerns, past behaviors related to opioid misuse, abuse, diversion.n=Pa evaluable for given question. Pa may choose more than 1 reason.
1.Primary Outcome
Title Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.
Arm/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 684
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
51.3
(47.5 to 55.1)
2.Primary Outcome
Title Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 684
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Transdermal Fentanyl (n= 77)
54.5
(42.8 to 65.9)
Immediate-release (IR) Hydrocodone (n= 164)
60.4
(52.4 to 67.9)
IR Hydromorphone (n= 22)
63.6
(40.7 to 82.8)
IR Oxycodone (n= 160)
48.1
(40.2 to 56.2)
IR Morphine (n= 53)
62.3
(47.9 to 75.2)
Methadone (n= 64)
40.6
(28.5 to 53.6)
Extended-release (ER) Oxycodone (n= 107)
42.1
(32.6 to 52.0)
ER Oxymorphone (n= 25)
56.0
(34.9 to 75.6)
Excluded Opioid/ Unclassified (n= 12)
8.3
(0.2 to 38.5)
3.Secondary Outcome
Title Duration to Titrate Participants to Stable Dose
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 351
Mean (Standard Deviation)
Unit of Measure: Days
20.0  (8.94)
4.Secondary Outcome
Title Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 351
Mean (Standard Deviation)
Unit of Measure: Days
Transdermal Fentanyl (n= 42) 17.8  (5.96)
IR Hydrocodone (n= 99) 20.7  (9.13)
IR Hydromorphone (n= 14) 24.3  (12.55)
IR Oxycodone (n= 77) 19.6  (8.35)
IR Morphine (n= 33) 18.8  (7.82)
Methadone (n= 26) 21.0  (8.70)
ER Oxycodone (n= 45) 20.3  (10.55)
ER Oxymorphone (n= 14) 19.8  (10.71)
Excluded Opioid/ Unclassified (n= 1) 7.0 [1]   (NA)
[1]
Standard deviation was not estimable since only one participant was evaluable.
5.Secondary Outcome
Title Number of Titration Steps to Achieve Stable Dose
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 351
Mean (Standard Deviation)
Unit of Measure: titration steps
2.4  (1.37)
6.Secondary Outcome
Title Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 351
Mean (Standard Deviation)
Unit of Measure: titration steps
Transdermal Fentanyl (n= 42) 2.0  (0.98)
IR Hydrocodone (n= 99) 2.6  (1.41)
IR Hydromorphone (n= 14) 2.6  (1.28)
IR Oxycodone (n= 77) 2.3  (1.40)
IR Morphine (n= 33) 2.3  (1.28)
Methadone (n= 26) 2.7  (1.52)
ER Oxycodone (n= 45) 2.4  (1.50)
ER Oxymorphone (n= 14) 2.5  (1.45)
Excluded Opioid/ Unclassified (n= 1) 1.0 [1]   (NA)
[1]
Standard deviation was not estimable since only one participant was evaluable.
7.Secondary Outcome
Title Percentage of Participants With Rescue Medications Usage During Titration
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 650
Measure Type: Number
Unit of Measure: Percentage of participants
79.8
8.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 322
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Visit 3 (Average Pain) (n=313) -2.23  (2.13)
Change at Visit 3 (Worst Pain) (n=313) -2.41  (2.49)
Change at Visit 3 (Least Pain) (n=321) -1.81  (2.33)
Change at Visit 3 (Relief) (n=0) NA [1]   (NA)
Change at Visit 3 (General Activity) (n=0) NA [1]   (NA)
Change at Visit 3 (Mood) (n=0) NA [1]   (NA)
Change at Visit 3 (Walking Ability) (n=0) NA [1]   (NA)
Change at Visit 3 (Normal Work) (n=0) NA [1]   (NA)
Change at Visit 3(Relationships with Others) (n=0) NA [1]   (NA)
Change at Visit 3 (Sleep) (n=0) NA [1]   (NA)
Change at Visit 3 (Enjoyment of Life) (n=0) NA [1]   (NA)
[1]
Data for this component of BPI was not summarized as analysis plan focused on average, worst and least pain components of the BPI.
9.Secondary Outcome
Title Investigator's Level of Satisfaction With the EMBEDA Conversion Guide
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 349
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
8.1  (2.11)
10.Other Pre-specified Outcome
Title Number of Participants With Aberrant Behaviors
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.
Arm/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 684
Measure Type: Number
Unit of Measure: Participants
217
11.Other Pre-specified Outcome
Title Number of Participants With Abnormal Urine Drug Test Results
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 684
Measure Type: Number
Unit of Measure: Participants
Baseline (n= 684) 160
Visit 3 (n= 351) 101
12.Other Pre-specified Outcome
Title Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 351
Measure Type: Number
Unit of Measure: Participants
85
13.Other Pre-specified Outcome
Title Number of Participants With Urine Drug Test Results Positive for Illicit Substances
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 684
Measure Type: Number
Unit of Measure: Participants
Baseline (n= 684) 51
Visit 3 (n= 351) 24
14.Other Pre-specified Outcome
Title Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EMBEDA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 684
Measure Type: Number
Unit of Measure: Participants
Baseline (n= 684) 122
Visit 3 (n= 351) 11
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title EMBEDA
Hide Arm/Group Description 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).
All-Cause Mortality
EMBEDA
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
EMBEDA
Affected / at Risk (%)
Total   24/684 (3.51%) 
Cardiac disorders   
Angina unstable * 1  1/684 (0.15%) 
Dyspnoea * 1  1/684 (0.15%) 
Myocardial infarction * 1  1/684 (0.15%) 
Right ventricular hypertrophy * 1  1/684 (0.15%) 
Tachycardia * 1  1/684 (0.15%) 
Endocrine disorders   
Hyperglycaemia * 1  1/684 (0.15%) 
Gastrointestinal disorders   
Constipation * 1  2/684 (0.29%) 
Diverticulitis * 1  1/684 (0.15%) 
Gastroenteritis * 1  1/684 (0.15%) 
Nausea * 1  2/684 (0.29%) 
Vomiting * 1  1/684 (0.15%) 
General disorders   
Chest pain * 1  1/684 (0.15%) 
Sudden death * 1  1/684 (0.15%) 
Hepatobiliary disorders   
Hepatitis acute * 1  1/684 (0.15%) 
Infections and infestations   
Skin infection * 1  1/684 (0.15%) 
Injury, poisoning and procedural complications   
Radius fracture * 1  1/684 (0.15%) 
Investigations   
Electrocardiogram t wave inversion * 1  1/684 (0.15%) 
Metabolism and nutrition disorders   
Dehydration * 1  2/684 (0.29%) 
Gout * 1  1/684 (0.15%) 
Musculoskeletal and connective tissue disorders   
Rhabdomyolysis * 1  1/684 (0.15%) 
Nervous system disorders   
Carotid artery disease * 1  1/684 (0.15%) 
Convulsion * 1  1/684 (0.15%) 
Dizziness * 1  1/684 (0.15%) 
Dyskinesia * 1  1/684 (0.15%) 
Transient ishaemic attack * 1  1/684 (0.15%) 
Psychiatric disorders   
Drug abuse * 1  1/684 (0.15%) 
Renal and urinary disorders   
Renal failure * 1  1/684 (0.15%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome * 1  1/684 (0.15%) 
Chronic obstructive pulmonary disease * 1  1/684 (0.15%) 
Pulmonary hypertension * 1  1/684 (0.15%) 
Respiratory distress * 1  1/684 (0.15%) 
Vascular disorders   
Hypertension * 1  1/684 (0.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EMBEDA
Affected / at Risk (%)
Total   331/684 (48.39%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/684 (0.15%) 
Lymphadenopathy * 1  1/684 (0.15%) 
Cardiac disorders   
Bradycardia * 1  1/684 (0.15%) 
Dyspnoea * 1  5/684 (0.73%) 
Oedema peripheral * 1  3/684 (0.44%) 
Palpitations * 1  1/684 (0.15%) 
Syncope * 1  2/684 (0.29%) 
Tachycardia * 1  1/684 (0.15%) 
Ear and labyrinth disorders   
Tinnitus * 1  1/684 (0.15%) 
Vertigo * 1  1/684 (0.15%) 
Endocrine disorders   
Diabetes mellitus * 1  1/684 (0.15%) 
Eye disorders   
Blindness transient * 1  1/684 (0.15%) 
Cataract * 1  1/684 (0.15%) 
Diplopia * 1  1/684 (0.15%) 
Eye pain * 1  1/684 (0.15%) 
Metamorphopsia * 1  1/684 (0.15%) 
Scleral haemorrhage * 1  1/684 (0.15%) 
Vision blurred * 1  6/684 (0.88%) 
Gastrointestinal disorders   
Abdominal discomfort * 1  3/684 (0.44%) 
Abdominal distension * 1  1/684 (0.15%) 
Abdominal pain * 1  2/684 (0.29%) 
Abdominal pain upper * 1  10/684 (1.46%) 
Breath odour * 1  1/684 (0.15%) 
Constipation * 1  74/684 (10.82%) 
Crohn's disease * 1  1/684 (0.15%) 
Diarrhoea * 1  8/684 (1.17%) 
Dry mouth * 1  11/684 (1.61%) 
Dysgeusia * 1  2/684 (0.29%) 
Dyspepsia * 1  4/684 (0.58%) 
Enteritis infectious * 1  1/684 (0.15%) 
Flatulence * 1  1/684 (0.15%) 
Food poisoning * 1  1/684 (0.15%) 
Gastritis * 1  1/684 (0.15%) 
Gastroenteritis viral * 1  2/684 (0.29%) 
Gastrooesophageal reflux disease * 1  1/684 (0.15%) 
Haematochezia * 1  1/684 (0.15%) 
Haemorrhoidal haemorrhage * 1  1/684 (0.15%) 
Nausea * 1  55/684 (8.04%) 
Painful defaecation * 1  1/684 (0.15%) 
Rectal haemorrhage * 1  1/684 (0.15%) 
Tooth disorder * 1  1/684 (0.15%) 
Tooth infection * 1  1/684 (0.15%) 
Toothache * 1  1/684 (0.15%) 
Vomiting * 1  33/684 (4.82%) 
General disorders   
Adverse drug reaction * 1  4/684 (0.58%) 
Adverse event * 1  1/684 (0.15%) 
Asthenia * 1  1/684 (0.15%) 
Burning sensation * 1  2/684 (0.29%) 
Chest discomfort * 1  2/684 (0.29%) 
Chest pain * 1  4/684 (0.58%) 
Chills * 1  5/684 (0.73%) 
Drug intolerance * 1  1/684 (0.15%) 
Drug withdrawal syndrome * 1  1/684 (0.15%) 
Face oedema * 1  1/684 (0.15%) 
Fatigue * 1  20/684 (2.92%) 
Feeling abnormal * 1  1/684 (0.15%) 
Feeling of body temperature change * 1  1/684 (0.15%) 
Flushing * 1  2/684 (0.29%) 
Gait disturbance * 1  1/684 (0.15%) 
Hot flush * 1  1/684 (0.15%) 
Hyperhidrosis * 1  7/684 (1.02%) 
Influenza like illness * 1  2/684 (0.29%) 
Irritability * 1  3/684 (0.44%) 
Lethargy * 1  5/684 (0.73%) 
Oedema * 1  3/684 (0.44%) 
Oedema peripheral * 1  6/684 (0.88%) 
Pain * 1  9/684 (1.32%) 
Thirst * 1  1/684 (0.15%) 
Withdrawal syndrome * 1  1/684 (0.15%) 
Hepatobiliary disorders   
Chronic hepatitis * 1  1/684 (0.15%) 
Immune system disorders   
Hypersensitivity * 1  1/684 (0.15%) 
Urticaria * 1  4/684 (0.58%) 
Infections and infestations   
Bronchitis * 1  4/684 (0.58%) 
Candidiasis * 1  1/684 (0.15%) 
Cellulitis * 1  1/684 (0.15%) 
Gastroenteritis viral * 1  1/684 (0.15%) 
Localised infection * 1  1/684 (0.15%) 
Nasopharyngitis * 1  8/684 (1.17%) 
Oral candidiasis * 1  1/684 (0.15%) 
Pharyngitis * 1  1/684 (0.15%) 
Pharyngitis streptococcal * 1  2/684 (0.29%) 
Sinusitis * 1  3/684 (0.44%) 
Staphylococcal infection * 1  1/684 (0.15%) 
Tooth infection * 1  1/684 (0.15%) 
Upper respiratory tract infection * 1  6/684 (0.88%) 
Urinary tract infection * 1  2/684 (0.29%) 
Vulvovaginal mycotic infection * 1  1/684 (0.15%) 
Injury, poisoning and procedural complications   
Accidental overdose * 1  1/684 (0.15%) 
Contusion * 1  3/684 (0.44%) 
Fall * 1  1/684 (0.15%) 
Foot fracture * 1  1/684 (0.15%) 
Foreign body * 1  1/684 (0.15%) 
Hand fracture * 1  1/684 (0.15%) 
Joint injury * 1  1/684 (0.15%) 
Muscle strain * 1  1/684 (0.15%) 
Rotator cuff syndrome * 1  1/684 (0.15%) 
Skeletal injury * 1  1/684 (0.15%) 
Skin laceration * 1  1/684 (0.15%) 
Tendonitis * 1  1/684 (0.15%) 
Thermal burn * 1  1/684 (0.15%) 
Investigations   
Blood pressure increased * 1  1/684 (0.15%) 
Intraocular pressure increased * 1  1/684 (0.15%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  5/684 (0.73%) 
Dehydration * 1  1/684 (0.15%) 
Gout * 1  1/684 (0.15%) 
Obesity * 1  1/684 (0.15%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  2/684 (0.29%) 
Back pain * 1  6/684 (0.88%) 
Gout * 1  2/684 (0.29%) 
Mobility decreased * 1  1/684 (0.15%) 
Muscle spasms * 1  5/684 (0.73%) 
Muscle twitching * 1  1/684 (0.15%) 
Musculoskeletal chest pain * 1  1/684 (0.15%) 
Myalgia * 1  4/684 (0.58%) 
Neck pain * 1  1/684 (0.15%) 
Pain in extremity * 1  3/684 (0.44%) 
Restless legs syndrome * 1  1/684 (0.15%) 
Synovial cyst * 1  1/684 (0.15%) 
Nervous system disorders   
Abnormal dreams * 1  2/684 (0.29%) 
Agitation * 1  2/684 (0.29%) 
Balance disorder * 1  1/684 (0.15%) 
Carpal tunnel syndrome * 1  1/684 (0.15%) 
Cognitive disorder * 1  4/684 (0.58%) 
Confusional state * 1  5/684 (0.73%) 
Disorientation * 1  2/684 (0.29%) 
Disturbance in attention * 1  3/684 (0.44%) 
Dizziness * 1  17/684 (2.49%) 
Dysaesthesia * 1  1/684 (0.15%) 
Dysarthria * 1  1/684 (0.15%) 
Dysgeusia * 1  1/684 (0.15%) 
Dysphemia * 1  1/684 (0.15%) 
Dysphonia * 1  2/684 (0.29%) 
Headache * 1  37/684 (5.41%) 
Hypoaesthesia * 1  1/684 (0.15%) 
Insomnia * 1  12/684 (1.75%) 
Paraesthesia * 1  1/684 (0.15%) 
Presyncope * 1  1/684 (0.15%) 
Restless legs syndrome * 1  1/684 (0.15%) 
Restlessness * 1  1/684 (0.15%) 
Sciatica * 1  1/684 (0.15%) 
Sedation * 1  4/684 (0.58%) 
Sinus headache * 1  1/684 (0.15%) 
Somnolence * 1  25/684 (3.65%) 
Tension headache * 1  1/684 (0.15%) 
Tremor * 1  4/684 (0.58%) 
Urinary incontinence * 1  1/684 (0.15%) 
Psychiatric disorders   
Affective disorder * 1  1/684 (0.15%) 
Aggression * 1  1/684 (0.15%) 
Anxiety * 1  2/684 (0.29%) 
Crying * 1  1/684 (0.15%) 
Delirium * 1  1/684 (0.15%) 
Depression * 1  3/684 (0.44%) 
Dysphoria * 1  1/684 (0.15%) 
Emotional disorder * 1  1/684 (0.15%) 
Enuresis * 1  1/684 (0.15%) 
Hallucination * 1  2/684 (0.29%) 
Hallucinations, mixed * 1  1/684 (0.15%) 
Hypersomnia * 1  3/684 (0.44%) 
Mood swings * 1  1/684 (0.15%) 
Nervousness * 1  3/684 (0.44%) 
Nightmare * 1  3/684 (0.44%) 
Throat tightness * 1  1/684 (0.15%) 
Renal and urinary disorders   
Dysuria * 1  4/684 (0.58%) 
Pollakiuria * 1  1/684 (0.15%) 
Urinary hesitation * 1  2/684 (0.29%) 
Urinary retention * 1  2/684 (0.29%) 
Reproductive system and breast disorders   
Ejaculation disorder * 1  1/684 (0.15%) 
Erectile dysfunction * 1  1/684 (0.15%) 
Hot flush * 1  1/684 (0.15%) 
Polymenorrhoea * 1  1/684 (0.15%) 
Sexual dysfunction * 1  1/684 (0.15%) 
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/684 (0.15%) 
Dyspnoea * 1  4/684 (0.58%) 
Nasal congestion * 1  3/684 (0.44%) 
Oropharyngeal pain * 1  3/684 (0.44%) 
Pulmonary congestion * 1  1/684 (0.15%) 
Rhinorrhoea * 1  2/684 (0.29%) 
Sinus congestion * 1  1/684 (0.15%) 
Sleep apnoea syndrome * 1  1/684 (0.15%) 
Sneezing * 1  1/684 (0.15%) 
Wheezing * 1  2/684 (0.29%) 
Skin and subcutaneous tissue disorders   
Acne * 1  2/684 (0.29%) 
Night sweats * 1  1/684 (0.15%) 
Pruritus * 1  18/684 (2.63%) 
Pruritus generalised * 1  1/684 (0.15%) 
Rash * 1  8/684 (1.17%) 
Rash generalised * 1  1/684 (0.15%) 
Swelling face * 1  1/684 (0.15%) 
Vascular disorders   
Deep vein thrombosis * 1  1/684 (0.15%) 
Hypertension * 1  1/684 (0.15%) 
Hypotension * 1  1/684 (0.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
The study was prematurely terminated due to drug supply issues.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01179191    
Other Study ID Numbers: ALO-01-10-4003
B4541001
First Submitted: July 30, 2010
First Posted: August 11, 2010
Results First Submitted: July 30, 2012
Results First Posted: September 5, 2012
Last Update Posted: October 11, 2012