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

被引：0

作者：

Shinkai, Masaharu ^{[1
]}

Katsumata, Noriyuki ^{[2
]}

Kawai, Shinichi ^{[3
]}

Kuyama, Shoichi ^{[4
]}

Sasaki, Osamu ^{[5
]}

Yanagita, Yasuhiro ^{[6
]}

Yoshida, Minoru ^{[7
]}

Uneda, Shima ^{[7
]}

Tsuji, Yasushi ^{[8
]}

Harada, Hidenori ^{[9
]}

Nishida, Yasunori ^{[10
]}

Sakamoto, Yasuhiro ^{[11
]}

Himeji, Daisuke ^{[12
]}

Arioka, Hitoshi ^{[13
]}

Sato, Kazuhiro ^{[14
]}

Katsuki, Ryo ^{[15
]}

Shomura, Hiroki ^{[16
]}

Nakano, Hideshi ^{[17
]}

Ohtani, Hideaki ^{[17
]}

Sasaki, Kazutaka ^{[17
]}

Adachi, Takeshi ^{[17
]}

机构：

[1] Tokyo Shinagawa Hosp, Tokyo, Japan

[2] Musashikosugi Hosp, Nippon Med Sch, Kawasaki, Kanagawa, Japan

[3] Toho Univ, Tokyo, Japan

[4] Natl Hosp Org, Iwakuni Clin Ctr, Yamaguchi, Japan

[5] Miyagi Canc Ctr, Natori, Miyagi, Japan

[6] Gunma Prefectural Canc Ctr, Gunma, Japan

[7] Japanese Red Cross Kumamoto Hosp, Kumamoto, Japan

[8] Tonan Hosp, Sapporo, Hokkaido, Japan

[9] Yamaguchi Univ, Yamaguchi, Japan

[10] Keiyukai Sapporo Hosp, Sapporo, Hokkaido, Japan

[11] Osaki Citizen Hosp, Osaki, Miyagi, Japan

[12] Miyazaki Prefectural Miyazaki Hosp, Miyazaki, Japan

[13] Yokohama Rosai Hosp, Yokohama, Kanagawa, Japan

[14] Nagaoka Red Cross Hosp, Niigata, Japan

[15] Natl Hosp Org, Ureshino Med Ctr, Saga, Japan

[16] Hokkaido Hosp, Japan Community Hlth Care Org, Sapporo, Hokkaido, Japan

[17] Nippon Zoki Pharmaceut Co Ltd, Dept Clin Dev, Osaka, Japan

来源：

SUPPORTIVE CARE IN CANCER | 2024年 / 32卷 / 01期

关键词：

Cancer pain; Tramadol; Sustained-release; Bilayer tablets; Randomized controlled study; Non-inferiority study; MEDICATION; MANAGEMENT; ADHERENCE;

D O I：

10.1007/s00520-023-08242-z

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PurposeWe investigated whether twice-daily administration of a bilayer tablet formulation of tramadol (35% immediate-release [IR] and 65% sustained-release) is as effective as four-times-daily IR tramadol capsules for managing cancer pain.MethodsThis randomized, double-blind, double-dummy, active-comparator, non-inferiority study enrolled opioid-naive patients using non-steroidal anti-inflammatory drugs or acetaminophen (paracetamol) to manage cancer pain and self-reported pain (mean value over 3 days >= 25 mm on a 100-mm visual analog scale [VAS]). Patients were randomized to either bilayer tablets or IR capsules for 14 days. The starting dose was 100 mg/day and could be escalated to 300 mg/day. The primary endpoint was the change in VAS (averaged over 3 days) for pain at rest from baseline to end of treatment/discontinuation.ResultsOverall, 251 patients were randomized. The baseline mean VAS at rest was 47.67 mm (range: 25.6-82.7 mm). In the full analysis set, the adjusted mean change in VAS was - 22.07 and - 19.08 mm in the bilayer tablet (n = 124) and IR capsule (n = 120) groups, respectively. The adjusted mean difference was - 2.99 mm (95% confidence interval [CI] - 7.96 to 1.99 mm). The upper 95% CI was less than the predefined non-inferiority margin of 7.5 mm. Other efficacy outcomes were similar in both groups. Adverse events were reported for 97/126 (77.0%) and 101/125 (80.8%) patients in the bilayer tablet and IR capsule groups, respectively.ConclusionTwice-daily administration of bilayer tramadol tablets was as effective as four-times-daily administration of IR capsules regarding the improvement in pain VAS, with comparable safety outcomes.Clinical trial registrationJapicCTI-184143/jRCT2080224082 (October 5, 2018).

引用

页数：12

共 39 条

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