Pain medicine (Malden, Mass.) · 2011
Long-term safety of Remoxy® (extended-release oxycodone) in patients with moderate to severe chronic osteoarthritis or low back pain.
Клиническое исследование III фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Friedmann Nadav, Klutzaritz Vicki, Webster Lynn
Аннотация
OBJECTIVE: Evaluate the long-term safety, tolerability, and efficacy of Remoxy® (extended-release oxycodone) in patients with chronic pain related to osteoarthritis of the hip and/or knee or chronic low back pain.
DESIGN: Open-label, 12-month, phase 3 trial.
SETTING: Fifty-nine US sites.
PATIENTS: Men and women with moderate to severe hip and/or knee pain caused by osteoarthritis or persistent moderate to severe low back pain.
INTERVENTION: Remoxy 5 mg twice daily, which could be increased in fixed increments up to 80 mg twice daily.
OUTCOME MEASURES: Safety and tolerability assessments included adverse events (AEs), laboratory tests, vital signs, physical examinations, and electrocardiograms. Efficacy was assessed through ratings of pain intensity, quality of analgesia, and global assessment of study drug.
RESULTS: Of the 828 patients enrolled, 823 received ≥1 dose of Remoxy, with 469 exposed for ≥180 days and 381 for ≥358 days. At least one AE was experienced by 678 patients (82%), the most common of which were opioid related, including constipation, nausea, and somnolence; 173 patients (21%) discontinued treatment because of AEs. No clinically relevant changes were seen in other safety assessments. Mean pain intensity scores decreased significantly from baseline at all time points (P < 0.001). At month 12, quality of analgesia and global assessment of study drug were rated positively (good, very good, or excellent) by 64% and 61% of patients (last observation carried forward), respectively.
CONCLUSIONS: Long-term treatment with Remoxy was safe, well tolerated, and efficacious in patients with chronic pain related to osteoarthritis of the hip and/or knee or chronic low back pain.
DESIGN: Open-label, 12-month, phase 3 trial.
SETTING: Fifty-nine US sites.
PATIENTS: Men and women with moderate to severe hip and/or knee pain caused by osteoarthritis or persistent moderate to severe low back pain.
INTERVENTION: Remoxy 5 mg twice daily, which could be increased in fixed increments up to 80 mg twice daily.
OUTCOME MEASURES: Safety and tolerability assessments included adverse events (AEs), laboratory tests, vital signs, physical examinations, and electrocardiograms. Efficacy was assessed through ratings of pain intensity, quality of analgesia, and global assessment of study drug.
RESULTS: Of the 828 patients enrolled, 823 received ≥1 dose of Remoxy, with 469 exposed for ≥180 days and 381 for ≥358 days. At least one AE was experienced by 678 patients (82%), the most common of which were opioid related, including constipation, nausea, and somnolence; 173 patients (21%) discontinued treatment because of AEs. No clinically relevant changes were seen in other safety assessments. Mean pain intensity scores decreased significantly from baseline at all time points (P < 0.001). At month 12, quality of analgesia and global assessment of study drug were rated positively (good, very good, or excellent) by 64% and 61% of patients (last observation carried forward), respectively.
CONCLUSIONS: Long-term treatment with Remoxy was safe, well tolerated, and efficacious in patients with chronic pain related to osteoarthritis of the hip and/or knee or chronic low back pain.