Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain
Phase 3
Completed
- Conditions
- Moderate-to-severe Chronic Noncancer Pain
- Interventions
- Registration Number
- NCT02603705
- Lead Sponsor
- Egalet Ltd
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of Egalet-002 in opioid-experienced patients with moderate-to-severe chronic noncancer pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 281
Inclusion Criteria
- Is a man or woman between 18 and 75 years of age.
- Has a clinical history of moderate-to-severe chronic noncancer pain ≥6 months.
- Has required opioid therapy for at least 14 days prior to Screening at a dose between 20 mg and 160 mg (inclusive) oxycodone/day (or opioid equivalent), and will, in the opinion of the investigator, continue to require opioid therapy (between 20 mg and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe pain for the duration of the study.
- Has pain either not adequately controlled on current opioid regimen, requires a change of opioid due to tolerability of current opioid regimen or in the opinion of the investigator, would benefit from changing opioid for another reason.
- 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 through the duration of the study), or is of non-childbearing potential.
- Other Criteria Apply
Exclusion Criteria
- Has cancer-related pain.
- Is receiving >240 mg oxycodone daily (or opioid equivalent) within 30 days before Screening.
- Has a history of attempted suicide.
- Has used a spinal infusion pump within 6 months before Screening.
- Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia) and/or respiratory disease (including chronic obstructive pulmonary disease or sleep apnea).
- Has positive urine toxicity screen for drugs of abuse (with the exception of prescribed medications).
- Has positive result for tetrahydrocannabinol (even if legally prescribed).
- Has current (or history of within the last 12 months) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine).
- Other Criteria Apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oxycodone extended-release Oxycodone extended-release Egalet abuse-deterrent, extended-release oxycodone tablet
- Primary Outcome Measures
Name Time Method Incidence of TEAEs during the Open-label Treatment Period, including those leading to treatment withdrawal, and/or abnormal physical examination findings, vital signs measurements, ECGs, and clinical laboratory test results, related to treatment 1 year
- Secondary Outcome Measures
Name Time Method Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period 1 year
Trial Locations
- Locations (39)
Site 334
🇺🇸Huntsville, Alabama, United States
Site 328
🇺🇸Tucson, Arizona, United States
Site 332
🇺🇸Jacksonville, Florida, United States
Site 340
🇺🇸Miami Gardens, Florida, United States
Site 320
🇺🇸Plantation, Florida, United States
Site 302
🇺🇸Tampa, Florida, United States
Site 315
🇺🇸Tampa, Florida, United States
Site 310
🇺🇸Winter Haven, Florida, United States
Site 316
🇺🇸Dawsonville, Georgia, United States
Site 311
🇺🇸Marietta, Georgia, United States
Scroll for more (29 remaining)Site 334🇺🇸Huntsville, Alabama, United States