Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain
Phase 3
Completed
- Conditions
- Moderate-to-severe Chronic Low Back Pain
- Interventions
- Drug: Placebo of oxycodone extended-release
- Registration Number
- NCT02716857
- Lead Sponsor
- Egalet Ltd
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 549
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxycodone extended-release Oxycodone extended-release Egalet ADER oxycodone tablet Placebo of Oxycodone extended-release Placebo of oxycodone extended-release Egalet ADER oxycodone placebo tablet
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (74)
Site 207
🇺🇸Birmingham, Alabama, United States
Site 202
🇺🇸Mobile, Alabama, United States
Site 253
🇺🇸Phoenix, Arizona, United States
Site 260
🇺🇸Phoenix, Arizona, United States
Site 268
🇺🇸Phoenix, Arizona, United States
Site 282
🇺🇸Tucson, Arizona, United States
Site 217
🇺🇸Anaheim, California, United States
Site 280
🇺🇸Anaheim, California, United States
Site 220
🇺🇸La Mesa, California, United States
Site 235
🇺🇸Laguna Hills, California, United States
Scroll for more (64 remaining)Site 207🇺🇸Birmingham, Alabama, United States