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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 December 2012
• Main ID: NCT01358526
• Date of registration: 20/05/2011
• Primary sponsor: Purdue Pharma LP
• Public title: 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
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Enriched Study Design to Assess the Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (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
• Date of first enrolment: May 2011
• Target sample size: 600
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01358526
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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 [ß
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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Low Back Pain

Intervention(s)

Drug: Oxycodone/Naloxone Controlled-release

Drug: Placebo

Primary Outcome(s)

The "average pain over the last 24 hours" at week 12 of the double-blind period [Time Frame: 24 hours (Week 12)]

Secondary Outcome(s)

Patient Global Impression of Change (PGIC) [Time Frame: Week 12]

Responder Analysis [Time Frame: Week 12]

The Sleep Disturbance Subscale of the MOS Sleep Scale [Time Frame: Weeks 1 - 12]

Secondary ID(s)

ONU3701

Source(s) of Monetary Support

Please refer to primary and secondary sponsors