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

Overview

Journal Contemp Clin Trials Commun

Date 2022 Aug 15

PMID 35967517

Authors

Takahiro Higashibata

Jun Hamano

Takaomi Kessoku

Shinya Kajiura

Mami Hirakawa

Yoshiki Horie

Masaki Shimizu

Shunsuke Oyamada

Keisuke Ariyoshi

Kota Kihara

Yohei Yamanaka

Kumi Konishi

Kosuke Doki

Yasuyuki Takashima

Manabu Horiuchi

Masato Homma

Takeshi Yamada

Yoshiyuki Yamamoto

Toshikazu Moriwaki

Tatsuya Morita

Atsushi Nakajima

Hiroka Nagaoka

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Naldemedine for Opioid-Induced Constipation in Patients With Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.

Hamano J, Higashibata T, Kessoku T, Kajiura S, Hirakawa M, Oyamada S J Clin Oncol. 2024; 42(35):4206-4217.

PMID: 39255425 PMC: 11637578. DOI: 10.1200/JCO.24.00381.

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