caa a22 4500 605490473 CHVBK 20210128100505.0 cr unu---uuuuu 210128e20150201xx s 000 0 eng 10.1007/s10147-014-0697-z doi (NATIONALLICENCE)springer-10.1007/s10147-014-0697-z Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined by titration for the treatment of breakthrough pain in Japanese cancer patients: a multicenter, randomized, placebo-controlled, double-blind phase III trial [Elektronische Daten] [Naohito Shimoyama, Ikuo Gomyo, Nobuyuki Katakami, Masakuni Okada, Nobuyuki Yukitoshi, Eri Ohta, Megumi Shimoyama] Abstract : Background: Breakthrough cancer pain typically has a rapid onset and relatively short duration. Due to this temporal profile, it may not be adequately relieved by oral opioid analgesics. The sublingual fentanyl orally disintegrating tablet is a formulation by which fentanyl can be rapidly absorbed across the oral mucosa producing rapid-onset analgesia, and which may be effective for breakthrough pain treatment. Methods: A multicenter, randomized, placebo-controlled, double-blind comparative study was conducted to evaluate the efficacy and safety of the sublingual fentanyl tablet at optimized doses for breakthrough pain treatment in cancer patients treated with strong opioid analgesics at fixed intervals. The optimal dose was determined by open-label dose titration. The efficacy and safety of a 12-week extended treatment were also evaluated. Results: Eleven of 42 subjects who received the sublingual fentanyl tablet experienced adverse drug reactions. Common reactions were somnolence, constipation, nausea, and vomiting. No serious adverse reactions occurred. Sublingual fentanyl tablets at optimal doses and placebo were administered to 37 subjects in a double-blinded manner. A significant analgesic effect of the sublingual fentanyl tablet was present compared to placebo at 30min after administration. The sublingual fentanyl tablet was also effective and safe during extended treatment, in which changes in basal opioid doses as well as sublingual fentanyl tablet doses were made as needed. Conclusion: Sublingual fentanyl tablets at doses determined by titration were effective and safe for breakthrough pain treatment in cancer patients treated with strong opioid analgesics at fixed intervals. Extended treatment up to 12weeks was also effective and safe. Japan Society of Clinical Oncology, 2014 Breakthrough pain nationallicence Cancer pain nationallicence Sublingual fentanyl tablet nationallicence Opioid nationallicence Dose titration nationallicence Shimoyama Naohito Department of Palliative Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, 105-8461, Tokyo, Japan aut Gomyo Ikuo Department of Palliative Medicine, Saito Yukoukai Hospital, 7-2-18 Saitoasagi, 567-0085, Ibaraki, Osaka, Japan aut Katakami Nobuyuki Division of Integrated Oncology, Foundation for Biomedical Research and Innovation, Institute of Biomedical Research and Innovation Hospital, 2-2 Minatojima Minamimachi, Chuo-ku, 650-0047, Kobe, Japan aut Okada Masakuni Department of Internal Medicine, Shakaihoken Kobe Central Hospital, 2-1-1 Soyamacho, Kita-ku, 651-1145, Kobe, Japan aut Yukitoshi Nobuyuki Development Division, Clinical Development Department 2, Kyowa Hakko Kirin Co., Ltd., 1-6-1 Ohtemachi, Chiyoda-ku, 100-8185, Tokyo, Japan aut Ohta Eri Development Division, Clinical Data Evaluation Department, Kyowa Hakko Kirin Co., Ltd., 1-6-1 Ohtemachi, Chiyoda-ku, 100-8185, Tokyo, Japan aut Shimoyama Megumi Department of Anesthesiology, Teikyo University Chiba Medical Center, 3426-3 Anesaki, 299-0111, Ichihara, Chiba, Japan aut International Journal of Clinical Oncology Springer Japan 20/1(2015-02-01), 198-206 1341-9625 20:1<198 2015 20 10147 https://doi.org/10.1007/s10147-014-0697-z text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-014-0697-z text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Shimoyama Naohito Department of Palliative Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, 105-8461, Tokyo, Japan aut NATIONALLICENCE 700 1- Gomyo Ikuo Department of Palliative Medicine, Saito Yukoukai Hospital, 7-2-18 Saitoasagi, 567-0085, Ibaraki, Osaka, Japan aut NATIONALLICENCE 700 1- Katakami Nobuyuki Division of Integrated Oncology, Foundation for Biomedical Research and Innovation, Institute of Biomedical Research and Innovation Hospital, 2-2 Minatojima Minamimachi, Chuo-ku, 650-0047, Kobe, Japan aut NATIONALLICENCE 700 1- Okada Masakuni Department of Internal Medicine, Shakaihoken Kobe Central Hospital, 2-1-1 Soyamacho, Kita-ku, 651-1145, Kobe, Japan aut NATIONALLICENCE 700 1- Yukitoshi Nobuyuki Development Division, Clinical Development Department 2, Kyowa Hakko Kirin Co., Ltd., 1-6-1 Ohtemachi, Chiyoda-ku, 100-8185, Tokyo, Japan aut NATIONALLICENCE 700 1- Ohta Eri Development Division, Clinical Data Evaluation Department, Kyowa Hakko Kirin Co., Ltd., 1-6-1 Ohtemachi, Chiyoda-ku, 100-8185, Tokyo, Japan aut NATIONALLICENCE 700 1- Shimoyama Megumi Department of Anesthesiology, Teikyo University Chiba Medical Center, 3426-3 Anesaki, 299-0111, Ichihara, Chiba, Japan aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/1(2015-02-01), 198-206 1341-9625 20:1<198 2015 20 10147