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
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| 024 | 7 | 0 | |a 10.1007/s10147-014-0697-z |2 doi |
| 035 | |a (NATIONALLICENCE)springer-10.1007/s10147-014-0697-z | ||
| 245 | 0 | 0 | |a 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 |h [Elektronische Daten] |c [Naohito Shimoyama, Ikuo Gomyo, Nobuyuki Katakami, Masakuni Okada, Nobuyuki Yukitoshi, Eri Ohta, Megumi Shimoyama] |
| 520 | 3 | |a 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. | |
| 540 | |a Japan Society of Clinical Oncology, 2014 | ||
| 690 | 7 | |a Breakthrough pain |2 nationallicence | |
| 690 | 7 | |a Cancer pain |2 nationallicence | |
| 690 | 7 | |a Sublingual fentanyl tablet |2 nationallicence | |
| 690 | 7 | |a Opioid |2 nationallicence | |
| 690 | 7 | |a Dose titration |2 nationallicence | |
| 700 | 1 | |a Shimoyama |D Naohito |u Department of Palliative Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, 105-8461, Tokyo, Japan |4 aut | |
| 700 | 1 | |a Gomyo |D Ikuo |u Department of Palliative Medicine, Saito Yukoukai Hospital, 7-2-18 Saitoasagi, 567-0085, Ibaraki, Osaka, Japan |4 aut | |
| 700 | 1 | |a Katakami |D Nobuyuki |u 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 |4 aut | |
| 700 | 1 | |a Okada |D Masakuni |u Department of Internal Medicine, Shakaihoken Kobe Central Hospital, 2-1-1 Soyamacho, Kita-ku, 651-1145, Kobe, Japan |4 aut | |
| 700 | 1 | |a Yukitoshi |D Nobuyuki |u Development Division, Clinical Development Department 2, Kyowa Hakko Kirin Co., Ltd., 1-6-1 Ohtemachi, Chiyoda-ku, 100-8185, Tokyo, Japan |4 aut | |
| 700 | 1 | |a Ohta |D Eri |u Development Division, Clinical Data Evaluation Department, Kyowa Hakko Kirin Co., Ltd., 1-6-1 Ohtemachi, Chiyoda-ku, 100-8185, Tokyo, Japan |4 aut | |
| 700 | 1 | |a Shimoyama |D Megumi |u Department of Anesthesiology, Teikyo University Chiba Medical Center, 3426-3 Anesaki, 299-0111, Ichihara, Chiba, Japan |4 aut | |
| 773 | 0 | |t International Journal of Clinical Oncology |d Springer Japan |g 20/1(2015-02-01), 198-206 |x 1341-9625 |q 20:1<198 |1 2015 |2 20 |o 10147 | |
| 856 | 4 | 0 | |u https://doi.org/10.1007/s10147-014-0697-z |q text/html |z Onlinezugriff via DOI |
| 898 | |a BK010053 |b XK010053 |c XK010000 | ||
| 900 | 7 | |a Metadata rights reserved |b Springer special CC-BY-NC licence |2 nationallicence | |
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| 950 | |B NATIONALLICENCE |P 856 |E 40 |u https://doi.org/10.1007/s10147-014-0697-z |q text/html |z Onlinezugriff via DOI | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Shimoyama |D Naohito |u Department of Palliative Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, 105-8461, Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Gomyo |D Ikuo |u Department of Palliative Medicine, Saito Yukoukai Hospital, 7-2-18 Saitoasagi, 567-0085, Ibaraki, Osaka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Katakami |D Nobuyuki |u 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 |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Okada |D Masakuni |u Department of Internal Medicine, Shakaihoken Kobe Central Hospital, 2-1-1 Soyamacho, Kita-ku, 651-1145, Kobe, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Yukitoshi |D Nobuyuki |u Development Division, Clinical Development Department 2, Kyowa Hakko Kirin Co., Ltd., 1-6-1 Ohtemachi, Chiyoda-ku, 100-8185, Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Ohta |D Eri |u Development Division, Clinical Data Evaluation Department, Kyowa Hakko Kirin Co., Ltd., 1-6-1 Ohtemachi, Chiyoda-ku, 100-8185, Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Shimoyama |D Megumi |u Department of Anesthesiology, Teikyo University Chiba Medical Center, 3426-3 Anesaki, 299-0111, Ichihara, Chiba, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 773 |E 0- |t International Journal of Clinical Oncology |d Springer Japan |g 20/1(2015-02-01), 198-206 |x 1341-9625 |q 20:1<198 |1 2015 |2 20 |o 10147 | ||