Yoshihara Tsutomu, Kessoku Takaomi, Takatsu Tomohiro, Misawa Noboru, Ashikari Keiichi, Fuyuki Akiko, Ohkubo Hidenori, Higurashi Takuma, Iwaki Michihiro, Kurihashi Takeo, Nakatogawa Machiko, Yamamoto Koji, Terada Izuru, Tanaka Yusuke, Nakajima Atsushi
Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Kanagawa, 236-0004, Japan.
Department of Internal Medicine, Kanagawa Dental University Yokohama Clinic, Yokohama, Kanagawa, 221-0835, Japan.
Contemp Clin Trials Commun. 2022 Oct 28;30:101019. doi: 10.1016/j.conctc.2022.101019. eCollection 2022 Dec.
Chronic constipation leads to poor quality of life, and treatment remains unsatisfactory for patients. In Japan, magnesium oxide has been commonly used as the first choice of treatment for constipation; however, there are some cases of low satisfaction with magnesium oxide treatment. Linaclotide has recently been used to treat chronic constipation. In this study, we will examine whether linaclotide improves symptoms and quality of life in patients showing insufficient response to magnesium oxide.
This is an exploratory multicenter open-label study. The target number of patients is 64: 32 patients with and 32 without abdominal symptoms. Patients with chronic idiopathic constipation or irritate bowel syndrome with constipation diagnosed according to the Rome-IV criteria are eligible. Patients prescribed 0.99-2 g/day of magnesium oxide for at least 4 weeks will be included. Those who consent to the study will continue taking magnesium oxide for 2-4 weeks, and defecation will be documented. Patients who meet the criteria will be prescribed linaclotide (0.5 mg) daily for 12 weeks. The primary endpoint is a change in the Japanese version of the Patient Assessment of Constipation Quality of Life (JPAC-QOL) score after 12 weeks of treatment.
This is the first study to investigate the usefulness of linaclotide as a second-line treatment for chronic constipation. We will test the efficacy of treatment of constipation in patients with inadequate response to magnesium oxide.
This study is registered with the Japan Registry of Clinical Trials (jRCT, jRCTs031200048).
慢性便秘会导致生活质量下降，且对患者的治疗效果仍不尽人意。在日本，氧化镁一直是便秘治疗的首选药物；然而，仍有一些患者对氧化镁治疗的满意度较低。利那洛肽最近被用于治疗慢性便秘。在本研究中，我们将探讨利那洛肽是否能改善对氧化镁反应不足的患者的症状和生活质量。
这是一项探索性多中心开放标签研究。患者目标数量为64例：32例有腹部症状，32例无腹部症状。符合罗马IV标准诊断的慢性特发性便秘或便秘型肠易激综合征患者 eligible。至少4周每天服用0.99 - 2克氧化镁的患者将被纳入。同意参加研究的患者将继续服用氧化镁2 - 4周，并记录排便情况。符合标准的患者将每天服用利那洛肽（0.5毫克），持续12周。主要终点是治疗12周后日本版便秘患者生活质量评估（JPAC - QOL）评分的变化。
这是第一项研究利那洛肽作为慢性便秘二线治疗药物有效性的研究。我们将测试利那洛肽对氧化镁反应不足的便秘患者的治疗效果。
本研究已在日本临床试验注册中心（jRCT，jRCTs031200048）注册。 （注：原文中“eligible”一词在中文语境下含义不太明确，这里按字面意思翻译为“符合条件的”，可能需要结合更多背景信息来准确理解其含义。）
