Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: Results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial

被引:157
作者
Caldwell, JR
Rapoport, RJ
Davis, JC
Offenberg, HL
Marker, HW
Roth, SH
Yuan, W
Eliot, L
Babul, N
Lynch, PM
机构
[1] Radiant Res, Daytona Beach, FL 32114 USA
[2] Truesdale Clin, Fall River, MA USA
[3] Capstone Clin Trials Inc, Birmingham, AL USA
[4] Memphis Med Specialists, Memphis, TN USA
[5] ArthoCare, Phoenix, AZ USA
[6] Ligand Pharmaceut Inc, San Diego, CA USA
[7] Theraquest Biosci LLC, E Norriton, PA USA
[8] Elan Pharmaceut Res Corp, Gainesville, FL USA
关键词
pain; osteoarthritis; once daily; morphine sulfate; extended-release; sustained-release;
D O I
10.1016/S0885-3924(02)00383-4
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
A randomized, 4-week, double-blind trial followed by an open-label extension trial assessed the efficacy and safety of a once-daily, extended-release morphine formulation (Avinza(TM), (previously referred to as Morphelan(TM))) in 295 patients with chronic, moderate-to-severe osteoarthitis pain who had failed to obtain adequate pain relief with NSAIDs and acetaminophen. Participants received one of four treatments: Avinza 30 mg once daily (QAM or QPM), MS Contin(R) 15 mg twice daily, or placebo twice daily. Patients (n = 181) received Avinza QAM or QPM during the 26-week open-label extension trial and could increase their dose to optimize pain control. Avinza and MS Contin reduced pain and measures versus placebo. Analgesic efficacy was comparable between Avinza and MS Contin; however, Avinza QAM demonstrated greater improvements in over-all quality of The most of AEs occurred at a similar common adverse events were constipation and nausea. The majority of incidence among the active treatment groups. (C) US. Cancer Pain Relief Committee, 2002.
引用
收藏
页码:278 / 291
页数:14
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