変形性膝関節症または腰痛症に伴う慢性疼痛を有する患者に対するトラマドール塩酸塩/アセトアミノフェン配合錠の第III相臨床試験―プラセボを対照としたランダム化治療中止二重盲検群間比較試験

Phase III Clinical Study of a Tramadol Hydrochloride/Acetaminophen Combination Tablet in Patients with Chronic Osteoarthritis Pain or Chronic Low Back Pain : A Randomized Withdrawal, Double-blind, Parallel-group, Placebo-controlled Study

　変形性膝関節症または腰痛症による慢性疼痛を有し，非ステロイド性消炎鎮痛薬(NSAIDs)では鎮痛効果不十分な患者を対象に，トラマドール塩酸塩/アセトアミノフェン配合錠(JNS013)の鎮痛効果および安全性をプラセボ対照のランダム化治療中止デザインによる二重盲検群間比較試験で検討した．JNS013の鎮痛効果不十分となるまでの期間はプラセボより有意に長く，強い鎮痛効果を認めた．また，主な副作用はオピオイド鎮痛薬に特徴的な症状が多く，安全性に大きな問題はなかった．以上から，JNS013は慢性疼痛に対して有用性の高い薬剤であることが示された．

　A randomized/withdrawal, double-blind, parallel-group, placebo-controlled study was conducted to investigate the analgesic effect and safety of a tramadol hydrochloride/acetaminophen combination tablet (JNS013) in patients with chronic pain caused by of the osteoarthritis knee or low back pain who did not respond well to treatment with nonsteroidal anti-inflammatory drugs (NSAIDs).　There was a significantly with JNS013 longer interval until the development of inadequate analgesia in comparison with the placebo, and JNS013 exerted a strong analgesic effect.　Moreover, many of the major side effects were symptoms characteristic of opioid analgesics, and there were no significant safety problems.　Based on the above, JNS013 appears to be highly promising as a drug for the control of chronic pain.