{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T13:56:51Z","timestamp":1762783011187},"reference-count":39,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,12,29]],"date-time":"2023-12-29T00:00:00Z","timestamp":1703808000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,12,29]],"date-time":"2023-12-29T00:00:00Z","timestamp":1703808000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Support Care Cancer"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>We 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This randomized, double-blind, double-dummy, active-comparator, non-inferiority study enrolled opioid-na\u00efve patients using non-steroidal anti-inflammatory drugs or acetaminophen (paracetamol) to manage cancer pain and self-reported pain (mean value over 3\u00a0days\u2009\u2265\u200925\u00a0mm on a 100-mm visual analog scale [VAS]). Patients were randomized to either bilayer tablets or IR capsules for 14\u00a0days. The starting dose was 100\u00a0mg\/day and could be escalated to 300\u00a0mg\/day. The primary endpoint was the change in VAS (averaged over 3\u00a0days) for pain at rest from baseline to end of treatment\/discontinuation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Overall, 251 patients were randomized. The baseline mean VAS at rest was 47.67\u00a0mm (range: 25.6\u201382.7\u00a0mm). In the full analysis set, the adjusted mean change in VAS was\u2009\u2212\u200922.07 and\u2009\u2212\u200919.08\u00a0mm in the bilayer tablet (n\u2009=\u2009124) and IR capsule (n\u2009=\u2009120) groups, respectively. The adjusted mean difference was\u2009\u2212\u20092.99\u00a0mm (95% confidence interval [CI]\u2009\u2212\u20097.96 to 1.99\u00a0mm). The upper 95% CI was less than the predefined non-inferiority margin of 7.5\u00a0mm. 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Twice-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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Clinical trial registration<\/jats:title>\n                <jats:p>JapicCTI-184143\/jRCT2080224082 (October 5, 2018).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00520-023-08242-z","type":"journal-article","created":{"date-parts":[[2023,12,29]],"date-time":"2023-12-29T05:02:45Z","timestamp":1703826165000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["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"],"prefix":"10.1007","volume":"32","author":[{"given":"Masaharu","family":"Shinkai","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noriyuki","family":"Katsumata","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinichi","family":"Kawai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shoichi","family":"Kuyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Osamu","family":"Sasaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuhiro","family":"Yanagita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Minoru","family":"Yoshida","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shima","family":"Uneda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasushi","family":"Tsuji","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hidenori","family":"Harada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasunori","family":"Nishida","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuhiro","family":"Sakamoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daisuke","family":"Himeji","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hitoshi","family":"Arioka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiro","family":"Sato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryo","family":"Katsuki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroki","family":"Shomura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideshi","family":"Nakano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideaki","family":"Ohtani","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazutaka","family":"Sasaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeshi","family":"Adachi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,12,29]]},"reference":[{"key":"8242_CR1","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1007\/s00520-022-07491-8","volume":"31","author":"V Haenen","year":"2023","unstructured":"Haenen V, Evenepoel M, De Baerdemaecker T, Meeus M, Devoogdt N, Morlion B, Dams L, Van Dijck S, Van der Gucht E, De Vrieze T, Vyvere TV, De Groef A (2023) Pain prevalence and characteristics in survivors of solid cancers: a systematic review and meta-analysis. 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Masaharu Shinkai received writing fees from Nippon Zoki in relation to this manuscript. Noriyuki Katsumata received honoraria from Nippon Zoki as a medical expert for this study.  Shinichi Kawai received research grants from Nippon Zoki and was involved in this study as a medical expert. Hideshi Nakano, Hideaki Ohtani, Kazutaka Sasaki, and Takeshi Adachi are employees of Nippon Zoki.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"This study was conducted in compliance with the Declaration of Helsinki, Good Clinical Practice, and Japanese ethical guidelines. The protocol was approved by the Institutional Review Board\/Ethics Committee at all 49 institutions at which the study was conducted, including the Institutional Review Board of Tokyo Shinagawa Hospital, Medical Corporation Association, Tokyokyojuno-kai.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients provided written informed consent to participate.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}],"article-number":"69"}}