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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• 作者：Naohito Shimoyama (1)
  Ikuo Gomyo (2) (3)
  Nobuyuki Katakami (4)
  Masakuni Okada (5) (6)
  Nobuyuki Yukitoshi (7)
  Eri Ohta (8)
  Megumi Shimoyama (9)
  
  1. Department of Palliative Medicine ; The Jikei University School of Medicine ; 3-25-8 Nishi-Shimbashi ; Minato-ku ; Tokyo ; 105-8461 ; Japan
  2. Department of Palliative Medicine ; Saito Yukoukai Hospital ; 7-2-18 Saitoasagi ; Ibaraki ; Osaka ; 567-0085 ; Japan
  3. Department of Palliative Medicine ; Japanese Red Cross Kitami Hospital ; 1 Kita-6-jo Higashi-2-chome ; Kitami ; Hokkaido ; 090-8666 ; Japan
  4. Division of Integrated Oncology ; Foundation for Biomedical Research and Innovation ; Institute of Biomedical Research and Innovation Hospital ; 2-2 Minatojima Minamimachi ; Chuo-ku ; Kobe ; 650-0047 ; Japan
  5. Department of Internal Medicine ; Shakaihoken Kobe Central Hospital ; 2-1-1 Soyamacho ; Kita-ku ; Kobe ; 651-1145 ; Japan
  6. Okada Internal Medicine Clinic ; 1-7-3 Soyamacho ; Kita-ku ; Kobe ; 651-1145 ; Japan
  7. Development Division ; Clinical Development Department 2 ; Kyowa Hakko Kirin Co. ; Ltd. ; 1-6-1 Ohtemachi ; Chiyoda-ku ; Tokyo ; 100-8185 ; Japan
  8. Development Division ; Clinical Data Evaluation Department ; Kyowa Hakko Kirin Co. ; Ltd. ; 1-6-1 Ohtemachi ; Chiyoda-ku ; Tokyo ; 100-8185 ; Japan
  9. Department of Anesthesiology ; Teikyo University Chiba Medical Center ; 3426-3 Anesaki ; Ichihara ; Chiba ; 299-0111 ; Japan
  
• 关键词：Breakthrough pain ; Cancer pain ; Sublingual fentanyl tablet ; Opioid ; Dose titration
• 刊名：International Journal of Clinical Oncology
• 出版年：2015
• 出版时间：February 2015
• 年：2015
• 卷：20
• 期：1
• 页码：198-206
• 全文大小：263 KB
• 参考文献：1. Potenoy RK, Hagen NA (1990) Breakthrough pain: definition, prevalence and characteristics. Pain 41:273鈥?81 CrossRef
  2. Simmonds MA (1999) Management of breakthrough pain due to cancer. Oncology (Williston Park) 13:1103鈥?108
  3. Bennett D, Burton AW, Fishman S et al (2005) Consensus panel recommendations for the assessment and management of breakthrough pain: Part 2. Management. Pharmacol Ther 30:354鈥?61
  4. Actiq SPC (2012) Cephalon Ltd, UK
  5. Bredenberg S, Duberg M, Lennernas B et al (2003) In vitro and in vivo evaluation of a new sublingual tablet system for rapid oromucosal absorption using fentanyl citrate as the active substance. Eur J Pharm Sci 20:327鈥?34 CrossRef
  6. Streisand JB, Busch MA, Egan TD et al (1998) Dose proportionality and pharmacokinetics of oral transmucosal fentanyl citrate. Anesthesiology 88:305鈥?09 CrossRef
  7. Lennernas B, Hedner T, Holmberg M et al (2004) Pharmacokinetics and tolerability of different doses of fentanyl following sublingual administration of a rapidly dissolving tablet to cancer patients: a new approach to treatment of incident pain. Br J Clin Pharmacol 59:249鈥?53 CrossRef
  8. England R, Maddocks M, Manderson C et al (2011) How practical are transmucosal fentanyl products for breakthrough cancer pain? novel use of placebo formulations to survey user opinion. BMJ Support Palliat Care 1:349鈥?51 CrossRef
  9. Christie JM, Simmonds M, Patt R et al (1998) Dose-titration, multicenter study of oral transmucosal fentanyl citrate for the treatment of breakthrough pain in cancer patients using transdermal fentanyl for persistent pain. J Clin Oncol 16:3238鈥?245
  10. Payne R, Coluzzi P, Hart L et al (2011) Long-term safety of oral transmucosal fentanyl citrate for breakthrough cancer pain. J Pain Symptom Manag 22:575鈥?83 CrossRef
  11. Cherny NI, Portenoy RK (1993) Cancer pain management: current strategy. Cancer 72(Suppl 11):3393鈥?415 CrossRef
  12. Yamaguchi T, Shima Y, Morita T et al (2013) Clinical guideline for pharmacological management of cancer pain: the Japanese society of palliative medicine recommendations. Jpn J Clin Oncol 43:896鈥?09 CrossRef
  13. Rauck RL, Tark M, Reyes E et al (2009) Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain. Curr Med Res Opin 25:2877鈥?885 CrossRef
  14. Abstral SPC (2013) ProStrakan Ltd, Galashiels, UK
  15. Abstral SPC (2013) Galena Biopharma, Inc., Lake Oswego, US
  16. Todd KH, Funk JP (1996) The minimum clinically important difference in physician-assigned visual analog pain scores. Acad Emerg Med 3:142鈥?46 CrossRef
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Oncology
  Surgical Oncology
  Radiotherapy
  Diagnostic Radiology
  Internal Medicine
  Pathology
  
• 出版者：Springer Japan
• ISSN：1437-7772

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