Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Oxycodone/Naloxone Controlled-release; Placebo
Intervention description: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours; Placebo tablets to match OXN taken orally every 12 hours
Intervention MeSH terms: Oxycodone; Naloxone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1095.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Low back pain; Chronic pain; Opioid; Moderate to severe chronic low back pain

Summary:

      The primary objective of this study is to assess the efficacy and safety of OXN compared to
      placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back
      pain who require around-the-clock opioid therapy.
    

Eligibility criteria:

        Inclusion Criteria include:

          -  Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back
             pain (lasting at least several hours daily) as their predominant pain condition for at
             least 3 months prior to screening period;

          -  The back pain must be related to nonmalignant and nonneuropathic conditions and
             without radiation or with only proximal radiation (above the knee);

          -  Subjects must be on opioid analgesic therapy for low back pain which:

          -  Has been ongoing for at least 4 weeks prior to the screening visit and,

          -  Consists of a stable opioid regimen at a total average daily dose equivalent to 20 to
             160 mg (inclusive) of morphine for the last 2 weeks prior to the screening visit.
             Subjects taking tramadol ≥ 100 mg daily on a stable regimen for the last 2 weeks prior
             to the screening visit will also meet this criterion;

          -  Subjects must require continuation of opioid analgesic treatment in the range of 40 to
             160 mg (inclusive) of morphine or its equivalent daily and be likely to benefit from
             chronic around-the-clock opioid therapy for the duration of the study;

          -  Subjects must have an average pain over the last 14 days score ≥ 5 (on an 11-point
             numerical rating scale [NRS]) at the screening visit, on their current opioid
             analgesic medication and, if applicable, nonopioid medication;

          -  Subjects must have an average pain over the last 24 hours score ≥ 5 (on an 11-point
             NRS) at the screening visit, on their current opioid analgesic medication and, if
             applicable, nonopioid medication;

          -  Subjects must be willing and able to be compliant with the protocol, capable of
             subjective evaluation, able to read and understand questionnaires, willing and able to
             use a diary per protocol, and read, understand, and sign the written informed consent
             in English.

        Exclusion Criteria include:

          -  Female subjects who are pregnant (positive serum beta human chorionic gonadotropin [β
             hCG] test) or lactating;

          -  Subjects with any contraindication or any history of hypersensitivity to oxycodone,
             naloxone, or other opioids. This does not include subjects who have experienced common
             opioid side effects (e.g., nausea, constipation);

          -  Subjects with acute spinal cord compression, acute compression fracture, seronegative
             spondyloarthropathy, acute nerve root compression, cauda equina compression,
             fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain
             syndrome), diabetic amyotrophy, meningitis, discitis, or back pain due to secondary
             infection, tumor, or postherpetic neuralgia;

          -  Subjects with gout, unless controlled on stable suppressive treatment with colchicine
             or uric-acid-lowering therapy without any attacks for ≥ 2 years and the subject has
             not been using nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors on a
             regular basis;

          -  Subjects with pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid
             arthritis or other inflammatory arthritis, or neuropathic pain conditions;

          -  Subjects who had surgical procedures directed towards the source of chronic low back
             pain within 6 months of the screening visit or planned during the study;

          -  Subjects with a history of opioid, alcohol, medication, or illicit drug abuse or
             addiction;

          -  Subjects who have received any investigational medication within 30 days of first dose
             of study drug;

          -  Subjects currently taking, or who have taken naloxone, naltrexone, methylnaltrexone,
             or alvimopan within 10 days before the screening visit;

          -  Subjects who have received study drug in a clinical study of oxycodone/naloxone
             controlled-release (OXN or ONU).

        Other protocol specific inclusion/exclusion criteria may apply.