一项多中心、双盲、随机、安慰剂对照试验的原理与设计，旨在研究纳地美定对癌症疼痛患者阿片类药物所致便秘的影响：一项研究方案。
Rationale and design of a multicenter, double-blinded, randomized, placebo-controlled trial to investigate the effects of naldemedine on opioid-induced constipation for patients with cancer pain: A study protocol.
作者信息
Higashibata Takahiro, Hamano Jun, Kessoku Takaomi, Kajiura Shinya, Hirakawa Mami, Horie Yoshiki, Shimizu Masaki, Oyamada Shunsuke, Ariyoshi Keisuke, Kihara Kota, Yamanaka Yohei, Konishi Kumi, Doki Kosuke, Takashima Yasuyuki, Horiuchi Manabu, Homma Masato, Yamada Takeshi, Yamamoto Yoshiyuki, Moriwaki Toshikazu, Morita Tatsuya, Nakajima Atsushi, Nagaoka Hiroka
机构信息
Palliative Care Team, Department of General Medicine and Primary Care, University of Tsukuba Hospital, 2-1-1 Amakubo, Tsukuba, 305-8576, Japan.
Faculty of Medicine, University of Tsukuba, 2-1-1 Amakubo, Tsukuba, 305-8576, Japan.
出版信息
Contemp Clin Trials Commun. 2022 Aug 5;29:100967. doi: 10.1016/j.conctc.2022.100967. eCollection 2022 Oct.
BACKGROUND
It is unclear which laxatives are appropriate to prevent opioid-induced constipation (OIC). This study will evaluate whether prophylactic use of naldemedine prevents OIC in patients with cancer who start opioid administration.
METHODS
This study is a multicenter, double-blinded, randomized, placebo-controlled trial. Patients who meet the eligibility criteria and give consent will be randomly assigned to the naldemedine or placebo group. Both groups will take each drug once a day after breakfast for 14 days.
RESULTS
The primary endpoint is the proportion of patients with a Bowel Function Index of less than 28.8 on Day 14. The secondary endpoints include assessment scales of the impact of constipation on comprehensive quality of life.
CONCLUSIONS
This is the first study proposed to assess the superiority of naldemedine over placebo in the prevention of OIC. If naldemedine is found to be effective in reducing OIC compared with the placebo, it will be regarded as a new standard for OIC prophylaxis at opioid initiation.
TRIAL REGISTRATION
jRCT identifier: jRCTs031200397. Registered March 5, 2021, https://rctportal.niph.go.jp/en/detail?trial_id=jRCTs031200397.
背景
目前尚不清楚哪种泻药适合预防阿片类药物引起的便秘（OIC）。本研究将评估预防性使用纳地美定是否能预防开始使用阿片类药物的癌症患者发生OIC。
方法
本研究是一项多中心、双盲、随机、安慰剂对照试验。符合入选标准并签署知情同意书的患者将被随机分配至纳地美定组或安慰剂组。两组患者均在早餐后每天服用一次药物，共服用14天。
结果
主要终点是第14天时肠道功能指数低于28.8的患者比例。次要终点包括便秘对综合生活质量影响的评估量表。
结论
这是第一项旨在评估纳地美定在预防OIC方面优于安慰剂的研究。如果发现纳地美定与安慰剂相比在减少OIC方面有效，它将被视为开始使用阿片类药物时预防OIC的新标准。
试验注册
jRCT标识符：jRCTs031200397。于2021年3月5日注册，https://rctportal.niph.go.jp/en/detail?trial_id=jRCTs031200397。
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