Moderate-to-severe Chronic Low Back Pain
Conditions
Brief summary
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
Interventions
DRUGPlacebo of oxycodone extended-release
Sponsors
Egalet Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed