Journal of opioid management · 2011
Efficacy and safety of an extended-release oxycodone (Remoxy) formulation in patients with moderate to severe osteoarthritic pain.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Friedmann Nadav, Klutzaritz Vicki, Webster Lynn
Аннотация
OBJECTIVE: To evaluate the efficacy and safety of an encapsulated, highly viscous formulation of extended-release oxycodone designed to resist common physical manipulation and chemical challenges (Remoxy; King Pharmaceuticals, Inc., Bristol, TV, which was acquired by Pfizer Inc. in March 2011).
DESIGN: An enriched enrollment randomized withdrawal trial design was used whereby patients entered a double-blind, multicenter, placebo-controlled trial after completing an open-label titration phase.
SETTING: Sixty-one US clinics.
PATIENTS: All patients (40-75 years) had experienced moderate to severe chronic osteoarthritic pain in the hip or knee for > or = 3 months.
INTERVENTIONS: During 2 weeks of open-label treatment (N = 558), patients were titrated from Remoxy 5 mg twice daily (bid) to 20 mg bid. Patients who tolerated the drug were randomly assigned to Remoxy or placebo bid for 12 weeks. Dose titration was permitted during weeks 1-4 (range, 10-80 mg/d) and fixed thereafter.
MAIN OUTCOME MEASURES: The area under the curve (AUC) for change in pain intensity (PI) scores from prerandomization to the end of the 12-week period was the primary endpoint. Patient assessment of quality of analgesia, global assessment of study medication, quality of life, and safety were also evaluated.
RESULTS: The mean AUC for change in PI score was significantly greater for Remoxy than for placebo (p = 0.007). Patients receiving Remoxy reported significantly better scores on quality of analgesia (p = 0.004) and global assessment of study medication (p = 0.007) when compared with patients receiving placebo. Remoxy had a safety profile consistent with other opioids.
CONCLUSIONS: Remoxy significantly improved analgesia among patients with moderate to severe chronic osteoarthritic pain with an adverse event profile similar to other opioids.
DESIGN: An enriched enrollment randomized withdrawal trial design was used whereby patients entered a double-blind, multicenter, placebo-controlled trial after completing an open-label titration phase.
SETTING: Sixty-one US clinics.
PATIENTS: All patients (40-75 years) had experienced moderate to severe chronic osteoarthritic pain in the hip or knee for > or = 3 months.
INTERVENTIONS: During 2 weeks of open-label treatment (N = 558), patients were titrated from Remoxy 5 mg twice daily (bid) to 20 mg bid. Patients who tolerated the drug were randomly assigned to Remoxy or placebo bid for 12 weeks. Dose titration was permitted during weeks 1-4 (range, 10-80 mg/d) and fixed thereafter.
MAIN OUTCOME MEASURES: The area under the curve (AUC) for change in pain intensity (PI) scores from prerandomization to the end of the 12-week period was the primary endpoint. Patient assessment of quality of analgesia, global assessment of study medication, quality of life, and safety were also evaluated.
RESULTS: The mean AUC for change in PI score was significantly greater for Remoxy than for placebo (p = 0.007). Patients receiving Remoxy reported significantly better scores on quality of analgesia (p = 0.004) and global assessment of study medication (p = 0.007) when compared with patients receiving placebo. Remoxy had a safety profile consistent with other opioids.
CONCLUSIONS: Remoxy significantly improved analgesia among patients with moderate to severe chronic osteoarthritic pain with an adverse event profile similar to other opioids.