Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
Condition: Chronic Noncancer Pain
Intervention: oxycodone HCl and naltrexone HCl extended-release capsules
Intervention description: 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.)
Intervention MeSH terms: Naltrexone; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Masking: None (Open Label)
Enrollment: 395.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic noncancer pain; oxycodone; naltrexone

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.
    

Eligibility 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.