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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01428583
First received: September 2, 2011
Last updated: September 28, 2016
Last verified: June 2016
Results First Received: September 28, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Chronic Noncancer Pain
Intervention: Drug: oxycodone HCl and naltrexone HCl extended-release capsules

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Oxycodone Hydrochloride (HCl) and Naltrexone HCl 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.

Participant Flow:   Overall Study
    Oxycodone Hydrochloride (HCl) and Naltrexone HCl
STARTED   395 
COMPLETED   158 
NOT COMPLETED   237 
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 
Unspecified                6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.

Reporting Groups
  Description
Oxycodone Hydrochloride (HCl) and Naltrexone HCl 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.

Baseline Measures
   Oxycodone Hydrochloride (HCl) and Naltrexone HCl 
Overall Participants Analyzed 
[Units: Participants]
 395 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.8  (12.10) 
Gender 
[Units: Participants]
 
Female   203 
Male   192 


  Outcome Measures
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1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions   [ Time Frame: Baseline up to end of study (2 weeks post-end of month 12) ]

2.  Secondary:   Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity   [ Time Frame: Baseline up to end of study (2 weeks post-end of month 12) ]

3.  Secondary:   Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score   [ Time Frame: Baseline up to Month 12 ]

4.  Secondary:   Subjective Opiate Withdrawal Scale (SOWS) Score   [ Time Frame: Baseline, Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ]

5.  Other Pre-specified:   Observed Steady-state Plasma Concentrations (Cobs) of Oxycodone   [ Time Frame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination ]

6.  Other Pre-specified:   Observed Steady-state Plasma Concentrations (Cobs) of Noroxycodone   [ Time Frame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination ]

7.  Other Pre-specified:   Observed Steady-state Plasma Concentrations (Cobs) of Naltrexone   [ Time Frame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination ]

8.  Other Pre-specified:   Observed Steady-state Plasma Concentrations (Cobs) of 6-Beta-naltrexol   [ Time Frame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination ]

9.  Other Pre-specified:   Time to Stabilization of Study Medication   [ Time Frame: Baseline up to Month 12 ]

10.  Other Pre-specified:   Duration of Exposure to Study Medication   [ Time Frame: Baseline up to 2 weeks after last dose ]

11.  Other Pre-specified:   Mean Daily Dose of Study Medication (Oxycodone Component)   [ 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) ]

12.  Other Pre-specified:   Number of Participants With Rescue Medication (Acetaminophen Tablets)   [ 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) ]

13.  Other Pre-specified:   Percentage of Participants With Response to Urine Drug Test   [ Time Frame: Screening, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination ]

14.  Other Pre-specified:   Percentage of Participants With Current Opioid Misuse Measure (COMM) Score of 9 or Above   [ Time Frame: Baseline, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination ]

15.  Other Pre-specified:   Mean Daily Dose of Immediate-release Oxycodone as Rescue Medication   [ Time Frame: Up to Week 4 ]

16.  Other Pre-specified:   Participants Global Assessment of Treatment Satisfaction   [ Time Frame: Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, end of treatment ]

17.  Other Pre-specified:   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   [ Time Frame: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination (ET) ]

18.  Other Pre-specified:   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   [ Time Frame: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination ]

19.  Other Pre-specified:   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   [ Time Frame: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Outcome measure reporting of Participants With Response to Urine Drug Test were based on qualitative point of contact results only.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01428583     History of Changes
Other Study ID Numbers: ALO-02-10-3001
B4531001 ( Other Identifier: Alias Study Number )
Study First Received: September 2, 2011
Results First Received: September 28, 2016
Last Updated: September 28, 2016
Health Authority: United States: Food and Drug Administration