A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

Study Overview
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Brief Summary
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The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.

Official Title
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A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Oxycodone/Naloxone controlled-release
* Drug: Oxycodone HCl controlled-release
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation; Subjects must have a self-reported history of opioid induced constipation (OIC). Exclusion Criteria include: Subjects with rheumatoid arthritis or other inflammatory arthritis; Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months; Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility; Subjects with chronic constipation not related to opioid use; 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 malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated. Other protocol specific inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OXN<br>Oxycodone/Naloxone controlled-release tablets (OXN) | Drug: Oxycodone/Naloxone controlled-release<br>* Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours<br>|
| Active Comparator: OXY<br>Oxycodone HCl controlled-release tablets (OXY) | Drug: Oxycodone HCl controlled-release<br>* Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours<br>* Other names: OxyContin;|
| Placebo Comparator: Placebo<br>Placebo tablets to match OXN or OXY | Drug: Placebo<br>* Placebo tablets to match OXN or OXY taken orally every 12 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall complete spontaneous bowel movement (CSBM) responder rates | The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY | Weeks 1 through 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSBM Responder at least 50% of the weeks in the double-blind period |  | Weeks 1 through 12 | 
| Laxative-free Responder at least 50% of the weeks in the double-blind period |  | Weeks 1 through 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Chronic pain, Opioid, Constipation, Moderate to severe