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

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


Lead Sponsor: Purdue Pharma LP

Source Purdue Pharma LP
Brief 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.

Overall Status Completed
Start Date May 2011
Completion Date November 2012
Primary Completion Date October 2012
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period 24 hours (Week 12)
Secondary Outcome
Measure Time Frame
The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 Weeks 4, 8, and 12
Patient Global Impression of Change (PGIC) Week 12
Enrollment 1095

Intervention Type: Drug

Intervention Name: Oxycodone/Naloxone Controlled-release

Description: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours

Arm Group Label: OXN


Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo tablets to match OXN taken orally every 12 hours

Arm Group Label: Placebo



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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

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Location Countries

United States

Verification Date

October 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: OXN

Type: Experimental

Description: Oxycodone/Naloxone Controlled-release Tablets (OXN)

Label: Placebo

Type: Placebo Comparator

Description: Placebo tablets to match OXN

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov