Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine the analgesic efficacy of Egalet-002 twice daily (BID) in patients with moderate-to-severe chronic low back pain

Official Title
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A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Egalet® Abuse-deterrent, Extended-release (ADER) Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Low Back Pain

Conditions
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Moderate-to-severe Chronic Low Back Pain

Intervention / Treatment
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* Drug: Oxycodone extended-release
* Drug: Placebo of oxycodone extended-release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is an English-speaking man or woman between 18 and 75 years of age who has given written informed consent. Has a clinical diagnosis of moderate-to-severe low back pain (Quebec Task Force Class 1 to 3) for ≥6 months. Is opioid naïve (ie, taking <20 mg oxycodone/day or opioid equivalent) or is opioid experienced (ie, taking a dose between 20 and 240 mg [inclusive] oxycodone/day or opioid equivalent) for management of moderate-to-severe CLBP at least 14 days prior to screening and will, in the opinion of the investigator, continue to require opioid therapy (between 20 and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe CLBP for the duration of the study. Has stable health, as determined by the investigator, If female, the patient is currently not pregnant, not breast-feeding, nor attempting to become pregnant (for 30 days before screening and throughout the duration of the study), or is of non-childbearing potential Exclusion Criteria: Has cancer-related pain. Has a history of receiving >240 mg oxycodone (or equivalent) daily within 30 days before screening. Has a lumbar spinal infusion pump in use or used within 6 months before screening. Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia) Has positive urine drug toxicity screen for illegal or non-prescribed drugs Has current (or history of within the last 5 years prior to screening) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine). Has positive result for cannabinoids (even if legally prescribed). Has a history of attempted suicide.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Oxycodone extended-release<br>Egalet ADER oxycodone tablet | Drug: Oxycodone extended-release<br> <br> * Other names: Egalet-002, Egalet ADER oxycodone;|
| Placebo Comparator: Placebo of Oxycodone extended-release<br>Egalet ADER oxycodone placebo tablet | Drug: Placebo of oxycodone extended-release<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: daily (past 24 hours) worst pain intensity score (WPI) |  | 16 Weeks | 
| Safety: Incidence of TEAEs, including those leading to treatment withdrawal, and/or abnormal physical examination findings, vital signs measurements, ECGs, and clinical laboratory test results, related to treatment |  | 16 weeks |