Phase III study of bilayer sustained-release tramadol tablets in patients with cancer pain: a double-blind parallel-group, non-inferiority study with immediate-release tramadol capsules as an active comparator.

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作者： Masaharu,Shinkai ^[1] ; Noriyuki,Katsumata ^[2] ; Shinichi,Kawai ^[3] ; Shoichi,Kuyama ^[4] ; Osamu,Sasaki ^[5] ; Yasuhiro,Yanagita ^[6] ; Minoru,Yoshida ^[7] ; Shima,Uneda ^[7] ; Yasushi,Tsuji ^[8] ; Hidenori,Harada ^[9] ; Yasunori,Nishida ^[10] ; Yasuhiro,Sakamoto ^[11] ; Daisuke,Himeji ^[12] ; Hitoshi,Arioka ^[13] ; Kazuhiro,Sato ^[14] ; Ryo,Katsuki ^[15] ; Hiroki,Shomura ^[16] ; Hideshi,Nakano ^[17] ; Hideaki,Ohtani ^[17] ; Kazutaka,Sasaki ^[17] ; Takeshi,Adachi ^[17]

作者单位： Tokyo Shinagawa Hospital, Tokyo, Japan. shinkai050169@gmail.com. ^[1] Nippon Medical School Musashikosugi Hospital, Kanagawa, Japan. ^[2] Toho University, Tokyo, Japan. ^[3] National Hospital Organization Iwakuni Clinical Center, Yamaguchi, Japan. ^[4] Miyagi Cancer Center, Miyagi, Japan. ^[5] Gunma Prefectural Cancer Center, Gunma, Japan. ^[6] Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan. ^[7] Tonan Hospital, Hokkaido, Japan. ^[8] Yamaguchi University Hospital, Yamaguchi, Japan. ^[9] Keiyukai Sapporo Hospital, Hokkaido, Japan. ^[10] Osaki Citizen Hospital, Miyagi, Japan. ^[11] Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan. ^[12] Yokohama Rosai Hospital, Kanagawa, Japan. ^[13] Nagaoka Red Cross Hospital, Niigata, Japan. ^[14] National Hospital Organization Ureshino Medical Center, Saga, Japan. ^[15] Japan Community Health Care Organization Hokkaido Hospital, Hokkaido, Japan. ^[16] Department of Clinical Development, Nippon Zoki Pharmaceutical Co., Ltd., Osaka, Japan. ^[17]

关键词 Bilayer tablets Cancer pain Non-inferiority study Randomized controlled study Sustained-release Tramadol