Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic low back pain requiring around-the-clock opioid analgesia for an extended period of time.

Official Title
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A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-Controlled, Safety, Tolerability, and Efficacy Study of Oxycodone DETERx™ Versus Placebo in Opioid-Experienced and Opioid-Naive Subjects With Moderate-to-Severe Chronic Low Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: Oxycodone DETERx
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female 18-75 years of age (inclusive) at the time of consent. Must have a clinical diagnosis of moderate-to-severe CLBP for a minimum of 6 months prior to screening. Must qualify for ATC opioid therapy for treatment of CLBP. Must be classified as non-malignant and non-neuropathic (Class 1 and 2), neuropathic (Class 3), or symptomatic for more than 6 months after low back pain surgery (Class 9) based on the Quebec Task Force Scale score. Female subjects of childbearing potential will use an acceptable method of birth control. Must be in general good health based on screening physical examination. Must be willing and able to comply with all study procedures and visit requirements. Exclusion Criteria: Known to be refractory or intolerant to the analgesic effects of opioids or have failed previous opioid therapy. A medical condition that would compromise the subject's ability to swallow, absorb, metabolize, or excrete the study drug, including (but not limited to) intractable nausea and/or vomiting and/or severe gastrointestinal narrowing (pathologic or iatrogenic), bowel obstruction, ileostomy, colostomy, or is suspected of having paralytic ileus. A surgical procedure for back pain within 6 months prior to the Screening Visit. Any other chronic pain condition other than CLBP that would interfere with the assessment of CLBP (e.g., osteoarthritis, rheumatoid arthritis, post-herpetic neuralgia, pain associated with diabetic neuropathy, fibromyalgia, migraine headaches requiring opioid therapy). Known history of major depressive disorder that is not controlled with medication or has other conditions that produce significant cognitive or emotional disability. Any clinically significant unstable medical abnormality or acute or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems. Known history of alcohol and/or drug abuse. Positive urine drug screen for illegal or non-prescribed drugs Known history of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime during the subject's life except pediatric febrile seizures. Known history of head injury within 6 months of Screening Visit. Current malignancy or a history within past 2 years of malignancy, with the exception of basal cell carcinoma or cervical carcinoma in situ that have been successfully treated. Positive for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or hepatitis C antibody Subject is not able or is unwilling to meet the study attendance requirements. Other protocol specific inclusion and exclusion criteria may apply.

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 DETERx<br> | Drug: Oxycodone DETERx<br>* 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo, divided into 2 doses, q12h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase | The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). | Randomized Baseline through Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-exit From the Study for All Causes | Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module. | Randomization Baseline through Week 12 | 
| Percent Reduction in Pain Intensity for Responders | Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity. | Screening Baseline through Week 12 | 
| Weekly Changes in Pain Intensity | Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain). | Randomization Baseline and weekly through Week 12 | 
| Rescue Medication Usage by Dose | Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study) | Randomization Baseline through Week 12 | 
| Rescue Medication Use by Dosage | Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study) | Randomization Baseline through Week 12 | 
| Patient Global Impression of Change (PGIC) | The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes very much improved, improved, a little improved, no change, a little worse, worse, and very much worse. | Screening Baseline through Week 12 | 
| Changes in Quality of Life | Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12. | Randomization Baseline through Week 12 | 
| Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ) | The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain. | Randomization Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Chronic back pain, Back pain, Opioid, Oxycodone, DETERx, Chronic pain, Chronic low back pain, CLBP, Xtampza