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: August 22, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 2, 2011

Last Updated Date

August 22, 2012

Start Date ^ICMJE

December 2010

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Subjects with adverse reactions (AEs assessed by the investigator as treatment-related) [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
Subjects with treatment-emergent adverse events [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01428583 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean Cobs of oxycodone at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean observed steady-state plasma concentration (Cobs) of oxycodone at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Mean time to stabilization of the total daily dose of study drug [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Mean duration of exposure to study drug [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 11 [ Time Frame: month 11 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 10 [ Time Frame: month 10 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 9 [ Time Frame: month 9 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 8 [ Time Frame: month 8 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 7 [ Time Frame: month 7 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 5 [ Time Frame: month 5 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 4 [ Time Frame: month 4 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 3 [ Time Frame: month 3 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 2 [ Time Frame: month 2 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during first 4 weeks [ Time Frame: week 1 to week 4 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 11 [ Time Frame: month 11 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 10 [ Time Frame: month 10 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 9 [ Time Frame: month 9 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 8 [ Time Frame: month 8 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 7 [ Time Frame: month 7 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
Subjects with a positive urine drug test for illicit drug substances or unaccounted opioids, or a negative urine test for the expected opioid oxycodone [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
Subjects with a Current Opioid Misuse Measure (COMM) score of 9 or above [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
Mean Cobs of 6-ß-naltrexol at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean Cobs of 6-ß-naltrexol at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean Cobs of 6-ß-naltrexol at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Mean Cobs of 6-ß-naltrexol at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean Cobs of 6-ß-naltrexol at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean Cobs of 6-ß-naltrexol at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Mean Cobs of 6-ß-naltrexol at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean Cobs of 6-ß-naltrexol at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 5 [ Time Frame: month 5 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 4 [ Time Frame: month 4 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 3 [ Time Frame: month 3 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 2 [ Time Frame: month 2 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during first 4 weeks [ Time Frame: week 1 to week 4 ] [ Designated as safety issue: No ]
Mean number of acetaminophen tablets as rescue medication during week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
Mean daily dosage of immediate-release oxycodone as rescue medication during week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
Mean daily dosage of immediate-release oxycodone as rescue medication during week 3 [ Time Frame: week 3 ] [ Designated as safety issue: No ]
Mean daily dosage of immediate-release oxycodone as rescue medication during week 2 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
Mean daily dosage of immediate-release oxycodone as rescue medication during week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 11 months [ Time Frame: 11 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 10 months [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 8 months [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 7 months [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 5 months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months or early discontinuation in 'pain right now' score [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months in 'pain right now' score [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
Mean change from baseline to 11 months in 'pain right now' score [ Time Frame: baseline to 11 months ] [ Designated as safety issue: No ]
Mean change from baseline to 10 months in 'pain right now' score [ Time Frame: baseline to 10 months ] [ Designated as safety issue: No ]
Mean change from baseline to 9 months in 'pain right now' score [ Time Frame: baseline to 9 months ] [ Designated as safety issue: No ]
Mean change from baseline to 8 months in 'pain right now' score [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]
Mean change from baseline to 7 months in 'pain right now' score [ Time Frame: baseline to 7 months ] [ Designated as safety issue: No ]
Mean change from baseline to 6 months in 'pain right now' score [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
Mean change from baseline to 5 months in 'pain right now' score [ Time Frame: baseline to 5 months ] [ Designated as safety issue: No ]
Mean change from baseline to 4 months in 'pain right now' score [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]
Mean change from baseline to 3 months in 'pain right now' score [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Mean change from baseline to 2 months in 'pain right now' score [ Time Frame: baseline to 2 months ] [ Designated as safety issue: No ]
Mean change from baseline to 4 weeks in 'pain right now' score [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: No ]
Mean change from baseline to 1 week in 'pain right now' score [ Time Frame: baseline to 1 week ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months or early discontinuation in 'average pain' score [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months or early discontinuation in 'worst pain' score [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months in 'average pain' score [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
Mean change from baseline to 11 months in 'average pain' score [ Time Frame: baseline to 11 months ] [ Designated as safety issue: No ]
Mean change from baseline to 10 months in 'average pain' score [ Time Frame: baseline to 10 months ] [ Designated as safety issue: No ]
Mean change from baseline to 9 months in 'average pain' score [ Time Frame: baseline to 9 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Subjects with treatment-emergent AEs by maximum intensity [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in heart rate [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in systolic blood pressure [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in diastolic blood pressure [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in respiratory rate [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in heart rate from 12-lead ECG [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in QRS interval from 12-lead ECG [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in QT interval from 12-lead ECG [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in QTc interval (Bazett's correction) from 12-lead ECG [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in PR interval from 12-lead ECG [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Subjects with treatment-emergent abnormal clinically significant results from 12-lead ECG at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation from 12-lead ECG [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in alanine aminotransferase (ALT) [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in alkaline phosphatase [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in aspartate aminotransferase (AST) [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in total bilirubin [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in blood urea nitrogen [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in serum creatinine [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in creatine phosphokinase [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in potassium [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in sodium [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in hematocrit [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in hemoglobin [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in platelet count [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in red blood cell count [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 12 months or early discontinuation in white blood cell count [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Subjects with clinical opiate withdrawal by intensity, determined by Clinical Opiate Withdrawal Scale (COWS) assessment [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean scores of clinical opiate withdrawal determined by Subjective Opiate Withdrawal Scale (SOWS) assessment [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: Yes ]
Mean change from baseline to 1 week in 'worst pain' score [ Time Frame: baseline to 1 week ] [ Designated as safety issue: No ]
Mean change from baseline to 4 weeks in 'worst pain' score [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: No ]
Mean change from baseline to 2 months in 'worst pain' score [ Time Frame: baseline to 2 months ] [ Designated as safety issue: No ]
Mean change from baseline to 3 months in 'worst pain' score [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Mean change from baseline to 4 months in 'worst pain' score [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]
Mean change from baseline to 5 months in 'worst pain' score [ Time Frame: baseline to 5 months ] [ Designated as safety issue: No ]
Mean change from baseline to 6 months in 'worst pain' score [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
Mean change from baseline to 7 months in 'worst pain' score [ Time Frame: baseline to 7 months ] [ Designated as safety issue: No ]
Mean change from baseline to 8 months in 'worst pain' score [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]
Mean change from baseline to 9 months in 'worst pain' score [ Time Frame: baseline to 9 months ] [ Designated as safety issue: No ]
Mean change from baseline to 10 months in 'worst pain' score [ Time Frame: baseline to 10 months ] [ Designated as safety issue: No ]
Mean change from baseline to 11 months in 'worst pain' score [ Time Frame: baseline to 11 months ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months in 'worst pain' score [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months or early discontinuation in 'worst pain' score [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean change from baseline to 1 week in 'least pain' score [ Time Frame: baseline to 1 week ] [ Designated as safety issue: No ]
Mean change from baseline to 4 weeks in 'least pain' score [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: No ]
Mean change from baseline to 2 months in 'least pain' score [ Time Frame: baseline to 2 months ] [ Designated as safety issue: No ]
Mean change from baseline to 3 months in 'least pain' score [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Mean change from baseline to 4 months in 'least pain' score [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]
Mean change from baseline to 5 months in 'least pain' score [ Time Frame: baseline to 5 months ] [ Designated as safety issue: No ]
Mean change from baseline to 6 months in 'least pain' score [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
Mean change from baseline to 7 months in 'least pain' score [ Time Frame: baseline to 7 months ] [ Designated as safety issue: No ]
Mean change from baseline to 8 months in 'least pain' score [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]
Mean change from baseline to 9 months in 'least pain' score [ Time Frame: baseline to 9 months ] [ Designated as safety issue: No ]
Mean change from baseline to 10 months in 'least pain' score [ Time Frame: baseline to 10 months ] [ Designated as safety issue: No ]
Mean change from baseline to 11 months in 'least pain' score [ Time Frame: baseline to 11 months ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months in 'least pain' score [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months or early discontinuation in 'least pain' score [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean change from baseline to 1 week in 'average pain' score [ Time Frame: baseline to 1 week ] [ Designated as safety issue: No ]
Mean change from baseline to 4 weeks in 'average pain' score [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: No ]
Mean change from baseline to 2 months in 'average pain' score [ Time Frame: baseline to 2 months ] [ Designated as safety issue: No ]
Mean change from baseline to 3 months in 'average pain' score [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Mean change from baseline to 4 months in 'average pain' score [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]
Mean change from baseline to 5 months in 'average pain' score [ Time Frame: baseline to 5 months ] [ Designated as safety issue: No ]
Mean change from baseline to 6 months in 'average pain' score [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
Mean change from baseline to 7 months in 'average pain' score [ Time Frame: baseline to 7 months ] [ Designated as safety issue: No ]
Mean change from baseline to 8 months in 'average pain' score [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]
Mean change from baseline to 9 months in 'average pain' score [ Time Frame: baseline to 9 months ] [ Designated as safety issue: No ]
Mean change from baseline to 10 months in 'average pain' score [ Time Frame: baseline to 10 months ] [ Designated as safety issue: No ]
Mean change from baseline to 11 months in 'average pain' score [ Time Frame: baseline to 11 months ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months in 'average pain' score [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months or early discontinuation in 'average pain' score [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean change from baseline to 1 week in 'pain right now' score [ Time Frame: baseline to 1 week ] [ Designated as safety issue: No ]
Mean change from baseline to 4 weeks in 'pain right now' score [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: No ]
Mean change from baseline to 2 months in 'pain right now' score [ Time Frame: baseline to 2 months ] [ Designated as safety issue: No ]
Mean change from baseline to 3 months in 'pain right now' score [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Mean change from baseline to 4 months in 'pain right now' score [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]
Mean change from baseline to 5 months in 'pain right now' score [ Time Frame: baseline to 5 months ] [ Designated as safety issue: No ]
Mean change from baseline to 6 months in 'pain right now' score [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
Mean change from baseline to 7 months in 'pain right now' score [ Time Frame: baseline to 7 months ] [ Designated as safety issue: No ]
Mean change from baseline to 8 months in 'pain right now' score [ Time Frame: baseline to 8 months ] [ Designated as safety issue: No ]
Mean change from baseline to 9 months in 'pain right now' score [ Time Frame: baseline to 9 months ] [ Designated as safety issue: No ]
Mean change from baseline to 10 months in 'pain right now' score [ Time Frame: baseline to 10 months ] [ Designated as safety issue: No ]
Mean change from baseline to 11 months in 'pain right now' score [ Time Frame: baseline to 11 months ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months in 'pain right now' score [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
Mean change from baseline to 12 months or early discontinuation in 'pain right now' score [ Time Frame: baseline to 12 months or early discontinuation ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 5 months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 7 months [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 8 months [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 10 months [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 11 months [ Time Frame: 11 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Subjects rating satisfied or very satisfied in global assessment of treatment satisfaction at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean daily dosage of immediate-release oxycodone as rescue medication during week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
Mean daily dosage of immediate-release oxycodone as rescue medication during week 2 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
Mean daily dosage of immediate-release oxycodone as rescue medication during week 3 [ Time Frame: week 3 ] [ Designated as safety issue: No ]
Mean daily dosage of immediate-release oxycodone as rescue medication during week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
Mean number of acetaminophen tablets as rescue medication during week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during first 4 weeks [ Time Frame: week 1 to week 4 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 2 [ Time Frame: month 2 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 3 [ Time Frame: month 3 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 4 [ Time Frame: month 4 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 5 [ Time Frame: month 5 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 7 [ Time Frame: month 7 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 8 [ Time Frame: month 8 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 9 [ Time Frame: month 9 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 10 [ Time Frame: month 10 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 11 [ Time Frame: month 11 ] [ Designated as safety issue: No ]
Mean weekly number of acetaminophen tablets as rescue medication during month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during first 4 weeks [ Time Frame: week 1 to week 4 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 2 [ Time Frame: month 2 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 3 [ Time Frame: month 3 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 4 [ Time Frame: month 4 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 5 [ Time Frame: month 5 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 7 [ Time Frame: month 7 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 8 [ Time Frame: month 8 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 9 [ Time Frame: month 9 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 10 [ Time Frame: month 10 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 11 [ Time Frame: month 11 ] [ Designated as safety issue: No ]
Mean daily dose of study drug during month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
Mean duration of exposure to study drug [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean time to stabilization of the total daily dose of study drug [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Mean observed steady-state plasma concentration (Cobs) of oxycodone at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean Cobs of oxycodone at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean Cobs of noroxycodone at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean Cobs of naltrexone at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
Mean Cobs of 6-β-naltrexol at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Mean Cobs of 6-β-naltrexol at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean Cobs of 6-β-naltrexol at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Mean Cobs of 6-β-naltrexol at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean Cobs of 6-β-naltrexol at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean Cobs of 6-β-naltrexol at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Mean Cobs of 6-β-naltrexol at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean Cobs of 6-β-naltrexol at 12 months or early discontinuation [ Time Frame: 12 months or early discontinuation ] [ Designated as safety issue: No ]
Subjects with a Current Opioid Misuse Measure (COMM) score of 9 or above [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
Subjects with a positive urine drug test for illicit drug substances or unaccounted opioids, or a negative urine test for the expected opioid oxycodone [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter, 12-Month, Open-Label, Single-Arm, Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

Brief Summary

The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Chronic Noncancer Pain

Intervention ^ICMJE

Drug: oxycodone HCl and naltrexone HCl extended-release capsules

Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)

Other Name: ALO-02

Study Arm (s)

Experimental: oxycodone HCl and naltrexone HCl extended-release capsules

Intervention: Drug: oxycodone HCl and naltrexone HCl extended-release capsules

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

396

Completion Date

May 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject has moderate to severe chronic noncancer pain (duration of at least 3 months) requiring a continuous around-the-clock opioid analgesic for an extended period of time. Conditions may include, but are not limited to, osteoarthritis, chronic low back pain, or other opioid -responsive pain conditions.
Subject agrees to refrain from taking opioid medications other than study drug during the study. (The exception is during the Pre-Treatment Period when the subject may continue current opioid therapy to guide first 4 weeks of the Treatment Period when the subject may administer immediate-release oxycodone to support conversion to study drug.)

Exclusion Criteria:

Subject has moderate or severe chronic pain due to cancer, migraine, recent trauma, infection, or other pain expected to be short-term (duration less than 3 months).
Subject has a documented history of alcohol or drug abuse within 1 year prior to study entry that in the Investigator's judgment would impact subject participation.
Subject has ongoing or active alcohol or drug abuse that in the Investigator's judgment would impact subject participation.
Subject has a positive urine drug test for illicit drug use or medications at screening without legitimate medical explanation.
Subject has a clinically significant medical condition (e.g., cardiovascular, neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological, immunological, rheumatological, metabolic, or psychiatric) or physical examination, vital signs (VS), 12-lead electrocardiogram (ECG), clinical laboratory abnormalities that in the opinion of the Investigator would impact the safety of the subject during study participation.
If female, the subject is pregnant or breast-feeding.
Subject has a known history or known hypersensitivity to oxycodone, oxycodone salts, naltrexone or acetaminophen,or pharmacological similar compounds.
Subject is historically non-responsive to oxycodone treatment or requires greater than 160 mg oxycodone in a 24-hour time interval.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01428583

Other Study ID Numbers ^ICMJE

ALO-02-10-3001, B4531001

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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