Chronic non Cancer Pain
Chronic Pain Study Details - Click Here
This is a Phase 3, open-label safety and tolerability study of Egalet-002, a twice-daily (BID) oral formulation of oxycodone hydrochloride with abuse-deterrent, extended-release (ADER) properties. Eligible patients will have moderate-to-severe chronic noncancer pain managed by opioid therapy. The duration of study participation for each patient will be a maximum of 56 weeks, consisting of a Screening Period (up to 3 weeks), an Open-label Treatment Period (52 weeks) that is initiated with patient Enrollment (Day 1), and a Follow-up Period (1 week) inclusive of the End-of-Study (EOS) Visit. A total of 18 scheduled visits are planned, with 16 scheduled visits occurring during the Open-label Treatment Period.
During the Screening Period, patients’ eligibility will be evaluated. Eligible patients are between 18 and 75 years of age, managed with 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 expected, in the opinion of the investigator, to require opioid therapy (between 20 mg and 240 mg oxycodone/day, inclusive) for management of their moderate-to-severe chronic noncancer pain for the duration of the study.
At Enrollment, the patient’s currently prescribed opioid medication(s) (daily immediate and extended release) will be converted to a starting dose of Egalet-002 using an algorithm based on standard conversion ratio estimates (Appendix A). The total daily dose of Egalet-002 is to be divided in 2 equal doses taken generally at the same time each day separated by approximately12 hours (with an acceptable window of ±1 hour). As needed, patients will be titrated to a stable dose of Egalet-002, which will be defined by investigator judgment to be a well-tolerated dose that results in adequate pain relief over the prior week with minimal use of rescue medication.
Titration of Egalet-002, to a maximum daily dosage of 240 mg, can occur no faster than every 4 days stepwise using the dose increments outlined until the stable, tolerated dose for adequate pain relief is identified by the investigator. During the first 2 weeks of the Open-label Treatment period, if a patient experiences signs and or symptoms of opioid withdrawal and has maximized allowable use of oxycodone immediate release (rescue medication), the investigator may choose to titrate (increase dose) of Egalet-002 faster than every 4 days, but not to exceed every 2 days. Tapering of Egalet-002 to the minimum daily dose of 20 mg can occur at an interval at the discretion of the investigator, using dose increments outlined. Titrations of Egalet-002 may occur, at scheduled office visits or unscheduled office visits, in between scheduled visits, under the direction of the investigator. Titrations can occur no faster than every 4 days. Patients who cannot achieve effective analgesia at or below the maximum daily dose of 240 mg Egalet-002 will be discontinued from the study. In this event, investigators should take care not to abruptly discontinue the study medication. The first titration or taper, only, may occur by phone between Visits 2 (initiation of Egalet-002) and 3 (next scheduled office visit).
Patients achieving a stable dose of Egalet-002 may continue receiving open-label treatment at that dose through Week 52. At the discretion of the investigator, dose adjustments of Egalet-002, either up or down, will be allowed for pain control and/or tolerability. Patients must contact their physician before making any adjustments to their total daily dose of study medication.
At any time during the Open-label Treatment Period, patients can use rescue medication (oxycodone IR 5 mg tablets; 1 or 2 tablets once every 4 hours [q4h] as needed [prn] up to a maximum of 8 tablets/day during Month 1 and up to a maximum of 4 tablets/day during Months 2 through 12) for inadequately controlled pain. Patients needing more than the outlined amounts of rescue medications should be instructed to contact the investigator. The amount of Eaglet-002 taken each day and use of rescue medication will be recorded by patients in a daily dosing log.
Safety and tolerability of Egalet-002 will be assessed based on treatment-emergent adverse events (TEAEs), vital signs measurements, electrocardiograms (EGCs) and hematologic, serum chemistry, and urinalysis laboratory parameters during the Open-label Treatment Period.
Efficacy of Egalet-002 will be assessed based on the Brief Pain Inventory (BPI)-Short Form (SF) questionnaire during the Open-label Treatment Period.
Patients who complete the Open-label Treatment Period will be followed for safety for 1 week.
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