Moderate-to-severe Chronic Noncancer Pain
Conditions
Keywords
chronic pain, opioid, oxycodone, non cancer pain, moderate to severe
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.
Interventions
Sponsors
Egalet Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period | 1 year |
Countries
United States
Outcome results
None listed