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Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

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: NCT01428583
Recruitment Status : Completed
First Posted : September 5, 2011
Results First Posted : November 21, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Chronic Noncancer Pain
Intervention Drug: oxycodone HCl and naltrexone HCl extended-release capsules
Enrollment 395
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Period Title: Overall Study
Started 395
Completed 158
Not Completed 237
Reason Not Completed
Adverse Event             75
Withdrawal by Subject             51
Lack of Efficacy             37
Lost to Follow-up             17
Death             1
Pregnancy             1
Protocol Violation             1
Physician Decision             12
Non-compliant             25
Confirmed positive urine drug test             8
Sponsor's request             3
Other             6
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Baseline Participants 395
Hide Baseline Analysis Population Description
Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 395 participants
53.8  (12.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 395 participants
Female
203
  51.4%
Male
192
  48.6%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE that was attributed to study drug in a participant who received study drug was defined as an adverse reaction. Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to end of study (2 weeks post-end of month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 395
Measure Type: Number
Unit of Measure: participants
Adverse event (all causalities) 343
Adverse reaction 207
2.Secondary Outcome
Title Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of adverse event was defined on the basis of severity of an event and was classified as; mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to end of study (2 weeks post-end of month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 395
Measure Type: Number
Unit of Measure: participants
Mild 94
Moderate 202
Severe 47
3.Secondary Outcome
Title Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score
Hide Description The presence and level of clinical opiate withdrawal signs or symptoms was determined by clinician-administered, clinical opiate withdrawal scale (COWS). It contains 11 common opiate withdrawal signs or symptoms rated by clinician (resting pulse rate, gastrointestinal upset, sweating, tremor, restlessness, yawning, pupil size, anxiety or irritability, bone or joint aches, gooseflesh skin, runny nose or tearing), rated on either 3-point, 4-point or 5-point scale, higher score indicated more symptoms of withdrawal. The total score is the sum of all items, ranging from 0 to 48, higher score indicated severe withdrawal. Participants were categorized as less than mild (score 0-4) mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36). Percentage of participants with mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36) were reported.
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 395
Measure Type: Number
Unit of Measure: percentage of participants
Mild (score 5-12) 13.2
Moderate (score 13-24) 0.0
Moderately severe (score 25-36) 0.3
Severe (score greater than 36) 0.0
4.Secondary Outcome
Title Subjective Opiate Withdrawal Scale (SOWS) Score
Hide Description The presence and level of clinical opiate withdrawal signs or symptoms was determined by participant-reported instrument, subjective opiate withdrawal scale (SOWS). It contains 16 symptoms of opiate withdrawal rated by the participant (anxiety, yawning, sweating, tearing, running nose, goose bumps, shaking, hot flashes, cold flashes, bone or muscle aches, restlessness, nauseous, vomiting, muscle twitch, stomach cramps and feel like using now). Each item is rated on a 5-point scale (0= not at all, 1= a little, 2= moderate, 3= quite a bit, 4= extreme). The total score is the sum of all items, ranging from 0 to 64, higher score indicated severe withdrawal.
Time Frame Baseline, Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here "n" signifies those participants who were evaluable at specified time point.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 395
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n= 395) 5.4  (5.49)
Week 1 (n= 362) 4.6  (6.15)
Week 4 (n= 307) 3.6  (4.32)
Month 2 (n= 252) 3.6  (4.70)
Month 3 (n= 221) 3.3  (4.53)
Month 4 (n= 210) 2.9  (4.30)
Month 5 (n= 198) 3.2  (4.56)
Month 6 (n= 190) 2.5  (3.27)
Month 7 (n= 185) 2.4  (4.07)
Month 8 (n= 180) 2.5  (3.74)
Month 9 (n= 174) 2.4  (4.08)
Month 10 (n= 167) 2.2  (3.25)
Month 11 (n= 162) 2.3  (3.53)
Month 12 (n= 154) 2.4  (4.09)
5.Other Pre-specified Outcome
Title Observed Steady-state Plasma Concentrations (Cobs) of Oxycodone
Hide Description [Not Specified]
Time Frame Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Observed Steady-state Plasma Concentrations (Cobs) of Noroxycodone
Hide Description Noroxycodone was a metabolite of Oxycodone.
Time Frame Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Observed Steady-state Plasma Concentrations (Cobs) of Naltrexone
Hide Description [Not Specified]
Time Frame Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Other Pre-specified Outcome
Title Observed Steady-state Plasma Concentrations (Cobs) of 6-Beta-naltrexol
Hide Description 6-Beta-naltrexol was a metabolite of naltrexone.
Time Frame Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title Time to Stabilization of Study Medication
Hide Description Stabilization was considered to have occurred when: total daily dose of oxycodone and naltrexone remained unchanged for greater than or equal to (>=) 3 consecutive days, daily acetaminophen used remained at 1 gram or less and immediate-release oxycodone was not being used as a rescue medication. Days to stabilization = date of stabilization - date of first dose + 1.
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 246
Median (Full Range)
Unit of Measure: days
11.0
(3 to 133)
10.Other Pre-specified Outcome
Title Duration of Exposure to Study Medication
Hide Description Duration of exposure to study medication during the course of the study was assessed.
Time Frame Baseline up to 2 weeks after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 395
Median (Full Range)
Unit of Measure: days
171.0
(1 to 406)
11.Other Pre-specified Outcome
Title Mean Daily Dose of Study Medication (Oxycodone Component)
Hide Description [Not Specified]
Time Frame Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 395
Mean (Standard Deviation)
Unit of Measure: milligram/day
Baseline-less than (<) Week 1 (n= 378) 38.6  (81.27)
Week 1-<4 (n= 344) 51.7  (35.53)
Week 4-<Month 2 (n= 292) 62.8  (42.65)
Month 2-< 3 (n= 238) 66.1  (40.35)
Month 3-<4 (n= 217) 68.0  (40.36)
Month 4-< 5 (n= 205) 68.6  (41.49)
Month 5-<6 (n= 193) 71.5  (43.58)
Month 6-<7 (n= 183) 73.1  (43.22)
Month 7- <8 (n= 183) 76.7  (43.76)
Month 8-<9 (n= 177) 77.7  (45.67)
Month 9-<10 (n= 169) 76.5  (44.58)
Month 10- <11 (n= 163) 77.9  (44.45)
Month 11- <12 (n= 160) 76.2  (43.14)
Month 12- <End of study (n= 82) 26.9  (22.79)
12.Other Pre-specified Outcome
Title Number of Participants With Rescue Medication (Acetaminophen Tablets)
Hide Description Participants had acetaminophen up to 2 grams per day during the treatment period of the study as rescue medication.
Time Frame Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) included all participants in the safety analysis set who had at least 1 pain intensity score reported during treatment. Here "n" signifies those participants who were evaluable at specified time point.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 387
Measure Type: Number
Unit of Measure: participants
Baseline-<Week 1 (n= 387) 256
Week 1-<4 (n= 361) 204
Week 4-<Month 2 (n= 305) 167
Month 2-<3 (n= 252) 124
Month 3-<4 (n= 222) 120
Month 4-<5 (n= 209) 112
Month 5-<6 (n= 199) 104
Month 6-<7 (n= 191) 96
Month 7-<8 (n= 185) 96
Month8-<9 (n= 179) 93
Month 9-<10 (n= 172) 79
Month 10-<11 (n= 167) 80
Month 11-<12 (n= 163) 85
Month 12-<End of study (n= 95) 30
13.Other Pre-specified Outcome
Title Percentage of Participants With Response to Urine Drug Test
Hide Description Participants with a positive urine drug test for illicit drug substances (marijuana, cocaine, amphetamines, methamphetamines, phencyclidine, and ecstasy), or unexpected drug substances (those other than reported by the participant as therapeutic concomitant medications such as opiates and methadone), or a negative urine test for the expected opioid (oxycodone) was assessed.
Time Frame Screening, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 395
Measure Type: Number
Unit of Measure: percentage of participants
Screening (n= 393) 86.8
Week 4 (n= 302) 41.7
Month 2 (n= 251) 43.0
Month 3 (n= 222) 43.2
Month 4 (n= 211) 39.3
Month 5 (n= 198) 41.4
Month 6 (n= 190) 44.2
Month 7 (n= 184) 41.8
Month 8 (n= 179) 44.1
Month 9 (n= 174) 44.8
Month 10 (n= 167) 44.3
Month 11 (n= 161) 50.3
Month 12 or early termination (n= 343) 57.1
14.Other Pre-specified Outcome
Title Percentage of Participants With Current Opioid Misuse Measure (COMM) Score of 9 or Above
Hide Description The COMM is a 17-item self-report questionnaire to monitor for aberrant medication-related behaviors among chronic pain participants. Participants are asked to indicate the frequency of individual behaviors on a scale from 0 to 4 (0 = never, 1 = seldom, 2 = sometimes, 3 = often, 4= very often). The total COMM score is the sum of the 17 item scores with a range from 0 to 68. Higher score indicated a higher risk for aberrant medication- related behavior. A score of 9 or higher was defined as high risk for aberrant medication- related behavior.
Time Frame Baseline, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here "n" signifies those participants who were evaluable at specified time point.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 395
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n= 395) 21.3
Week 4 (n= 302) 8.9
Month 2 (n= 250) 10.0
Month 3 (n= 217) 8.3
Month 4 (n= 208) 6.7
Month 5 (n= 197) 5.1
Month 6 (n= 189) 2.6
Month 7 (n= 185) 3.2
Month 8 (n= 181) 5.0
Month 9 (n= 174) 5.7
Month 10 (n= 167) 4.8
Month 11 (n= 162) 3.7
Month 12 or early termination (n= 333) 15.3
15.Other Pre-specified Outcome
Title Mean Daily Dose of Immediate-release Oxycodone as Rescue Medication
Hide Description Immediate-release oxycodone as a single ingredient product was used as a rescue medication only during the first 4 weeks of the treatment period to support the initiation of oxycodone HCl and naltrexone HCl treatment.
Time Frame Up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Data for mean daily dose of immediate-release oxycodone was not reported because as per protocol and analysis plan it was not planned to be summarized.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
16.Other Pre-specified Outcome
Title Participants Global Assessment of Treatment Satisfaction
Hide Description Participant global assessment of treatment satisfaction was scored on a 5-point categorical scale based on response to the question "Please rate your overall satisfaction with the study drug you received?" where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied.
Time Frame Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 387
Mean (Standard Deviation)
Unit of Measure: unit on a scale
Week 1 (n= 361) 3.3  (1.03)
Week 4 (n= 304) 3.8  (0.99)
Month 2 (n= 251) 3.9  (0.94)
Month 3 (n= 220) 4.1  (0.88)
Month 4 (n= 209) 4.1  (0.93)
Month 5 (n= 197) 4.2  (0.90)
Month 6 (n= 190) 4.2  (0.89)
Month 7 (n= 185) 4.2  (0.81)
Month 8 (n= 181) 4.2  (0.81)
Month 9 (n= 174) 4.2  (0.96)
Month 10 (n= 167) 4.3  (0.73)
Month 11 (n= 162) 4.3  (0.79)
Month 12 (n= 154) 4.2  (1.04)
End of treatment (n= 372) 3.6  (1.27)
17.Other Pre-specified Outcome
Title Mean Change From Baseline in Pain Right Now Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
Hide Description The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. "Pain right now" was reported.
Time Frame Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination (ET)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 387
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n= 386) 5.6  (2.17)
Change at Week 1 (n= 360) -0.6  (2.16)
Change at Week 4 (n= 306) -1.3  (2.29)
Change at Month 2 (n= 251) -1.6  (2.36)
Change at Month 3 (n= 218) -1.7  (2.34)
Change at Month 4 (n= 208) -1.8  (2.29)
Change at Month 5 (n= 197) -1.8  (2.29)
Change at Month 6 (n= 189) -1.8  (2.38)
Change at Month 7 (n= 184) -1.7  (2.40)
Change at Month 8 (n= 180) -1.8  (2.48)
Change at Month 9 (n= 172) -1.8  (2.39)
Change at Month 10 (n= 166) -1.7  (2.41)
Change at Month 11 (n= 161) -1.9  (2.31)
Change at Month 12 (n= 153) -1.9  (2.44)
Change at Month 12/ET (n= 373) -1.4  (2.58)
18.Other Pre-specified Outcome
Title Mean Change From Baseline in Average Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
Hide Description The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain on average in the last 24 hours" was reported.
Time Frame Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 387
Mean (Standard Deviation)
Unit of Measure: unit on a scale
Baseline (n= 384) 5.9  (1.74)
Change at Week 1 (n= 357) -0.6  (1.64)
Change at Week 4 (n= 303) -1.2  (1.95)
Change at Month 2 (n= 250) -1.5  (2.11)
Change at Month 3 (n= 219) -1.7  (2.12)
Change at Month 4 (n= 206) -1.7  (2.04)
Change at Month 5 (n= 196) -1.7  (2.02)
Change at Month 6 (n= 189) -1.7  (2.11)
Change at Month 7 (n= 184) -1.7  (2.17)
Change at Month 8 (n= 180) -1.9  (2.12)
Change at Month 9 (n= 173) -1.8  (2.21)
Change at Month 10 (n= 166) -1.7  (2.26)
Change at Month 11 (n= 161) -1.8  (2.02)
Change at Month 12 (n= 153) -1.9  (2.23)
Change at Month 12/ET (n= 372) -1.3  (2.32)
19.Other Pre-specified Outcome
Title Mean Change From Baseline in Worst Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
Hide Description The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. "Pain at its worst in the last 24 hours" was reported.
Time Frame Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluable at specified time point.
Arm/Group Title Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description:
Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Overall Number of Participants Analyzed 387
Mean (Standard Deviation)
Unit of Measure: unit on a scale
Baseline (n= 382) 7.4  (1.63)
Change at Week 1 (n= 354) -0.7  (1.96)
Change at Week 4 (n= 301) -1.3  (2.24)
Change at Month 2 (n= 248) -1.6  (2.39)
Change at Month 3 (n= 219) -1.8  (2.32)
Change at Month 4 (n= 208) -1.9  (2.12)
Change at Month 5 (n= 197) -1.9  (2.41)
Change at Month 6 (n= 189) -2.0  (2.30)
Change at Month 7 (n= 184) -2.0  (2.43)
Change at Month 8 (n= 180) -2.0  (2.31)
Change at Month 9 (n= 173) -2.2  (2.48)
Change at Month 10 (n= 166) -2.1  (2.50)
Change at Month 11 (n= 161) -2.2  (2.41)
Change at Month 12 (n= 153) -2.2  (2.44)
Change at Month 12/ET (n= 368) -1.6  (2.52)
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 Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Hide Arm/Group Description Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
All-Cause Mortality
Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Affected / at Risk (%)
Total   26/395 (6.58%) 
Blood and lymphatic system disorders   
Hypochromic anaemia * 1  1/395 (0.25%) 
Cardiac disorders   
Acute myocardial infarction * 1  2/395 (0.51%) 
Cardiac failure congestive * 1  1/395 (0.25%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/395 (0.25%) 
Hiatus hernia * 1  1/395 (0.25%) 
Pancreatitis acute * 1  1/395 (0.25%) 
Small intestinal obstruction * 1  1/395 (0.25%) 
General disorders   
Chest discomfort * 1  1/395 (0.25%) 
Chest pain * 1  1/395 (0.25%) 
Non-cardiac chest pain * 1  2/395 (0.51%) 
Hepatobiliary disorders   
Cholecystitis * 1  1/395 (0.25%) 
Cholelithiasis * 1  1/395 (0.25%) 
Infections and infestations   
Infected skin ulcer * 1  1/395 (0.25%) 
Osteomyelitis * 1  1/395 (0.25%) 
Pneumonia * 1  2/395 (0.51%) 
Urinary tract infection * 1  1/395 (0.25%) 
Investigations   
Blood pressure increased * 1  1/395 (0.25%) 
Metabolism and nutrition disorders   
Hypoglycaemia * 1  1/395 (0.25%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc degeneration * 1  1/395 (0.25%) 
Muscular weakness * 1  1/395 (0.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Anal cancer * 1  1/395 (0.25%) 
Nervous system disorders   
Cerebrovascular accident * 1  1/395 (0.25%) 
Convulsion * 1  2/395 (0.51%) 
Psychiatric disorders   
Mental status changes * 1  1/395 (0.25%) 
Renal and urinary disorders   
Nephrolithiasis * 1  2/395 (0.51%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease * 1  1/395 (0.25%) 
Lung infiltration * 1  1/395 (0.25%) 
Pleural effusion * 1  1/395 (0.25%) 
*
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 5%
Oxycodone Hydrochloride (HCl) and Naltrexone HCl
Affected / at Risk (%)
Total   272/395 (68.86%) 
Gastrointestinal disorders   
Nausea * 1  100/395 (25.32%) 
Constipation * 1  84/395 (21.27%) 
Vomiting * 1  55/395 (13.92%) 
Diarrhoea * 1  36/395 (9.11%) 
General disorders   
Fatigue * 1  36/395 (9.11%) 
Infections and infestations   
Upper respiratory tract infection * 1  24/395 (6.08%) 
Influenza * 1  20/395 (5.06%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  25/395 (6.33%) 
Nervous system disorders   
Headache * 1  46/395 (11.65%) 
Somnolence * 1  37/395 (9.37%) 
Dizziness * 1  34/395 (8.61%) 
Psychiatric disorders   
Anxiety * 1  30/395 (7.59%) 
Insomnia * 1  20/395 (5.06%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis * 1  24/395 (6.08%) 
Pruritus * 1  21/395 (5.32%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Outcome measure reporting of Participants With Response to Urine Drug Test were based on qualitative point of contact results only.
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01428583    
Other Study ID Numbers: ALO-02-10-3001
B4531001 ( Other Identifier: Alias Study Number )
First Submitted: September 2, 2011
First Posted: September 5, 2011
Results First Submitted: September 28, 2016
Results First Posted: November 21, 2016
Last Update Posted: November 21, 2016