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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: July 8, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Chronic Noncancer Pain
Drug: oxycodone HCl and naltrexone HCl extended-release capsules
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 396
Study Start Date: December 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxycodone HCl and naltrexone HCl extended-release capsules 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428583

  Show 32 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01428583     History of Changes
Other Study ID Numbers: ALO-02-10-3001, B4531001
Study First Received: September 2, 2011
Last Updated: July 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Chronic noncancer pain
oxycodone
naltrexone

Additional relevant MeSH terms:
Naltrexone
Oxycodone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014