The exploratory, multicenter, open-label study to evaluate the effect of linaclotide on the Japanese version of Patient Assessment of Constipation of Quality of Life Scale (JPAC-QOL) in patients whose QOL scale is poor in spite of taking magnesium oxide with adult chronic constipation

Yoshihara Tsutomu0 个研究点目标入组 64 人开始时间: 2020年6月9日最近更新: 2023年10月17日

适应症

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 64

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 < 85age old（—）
性别: All

入选标准

•1. Patients with written informed consent.
•2. Patients diagnosed with choronic constipation (CC) or constipation-predominant irritable bowel syndrome (IBS-C) based on Rome IV criteria and prescribed 0.99-2g of magnesium oxide per day as a first-line drug for 4 weeks or more.
•3. Outpatients whose ages are between 20 and 85 years old at the time of obtaining consent.
•4. For female patients, patients who meet any of the following conditions.
•Patients who are not likely to become pregnant are any of the following;Patients who have menopause at the time of enrollment (without menses for more than 1 year).Patients who have undergone surgical procedures (hysterectomy, ovariectomy, contraceptive surgery, etc.) and are judged to be unlikely to become pregnant by the researcher.
•Patients who are likely to become pregnant are as follows; Patients who agreed not to become pregnant during the study period and 4 weeks after taking the drugs.

排除标准

•1. Patients with a history of surgical resection of the stomach, gallbladder, small intestine, or large intestine (except for appendicitis and polypectomy of benign polyps).
•2. Patients with a history of, or currently suffering from, inflammatory bowel disease (Crohn's disease or ulcerative colitis)
•3. Patients with, or currently have, ischemic colitis.
•4. Patients currently suffering from infectious enteritis.
•5. Patients currently suffering from hyperthyroidism or hypothyroidism.
•6. Patients with mechanical bowel obstruction (due to hernia, etc.).
•7. Patients with megacolon or megarectum.
•8. Patients currently suffering from constipation due to anorectal dysfunction.
•9. Patients currently suffering from constipation due to drugs.
•10. Patients currently suffering from constipation due to organic diseases.
•11. Patients currently suffering from active peptic ulcer.
•12. Patients with severe depression or anxiety symptoms who are judged to affect the efficacy evaluation.
•13. Patients who have had or are currently abusing drugs or alcohol within one year before obtaining consent.
•14. Patients who have used or are planning to use any of the following prohibited drugs in the past.
•Lubiprostone, Elobixibat, Polyethylene glycol, Lactulose
•15. Patients who have prescribed or are planning to prescribe antiparkinson, antipsychotic, antimanic or psychostimulant drugs at the time of registration.
•16. Patients who have performed or are planning to perform the following prohibited tests 3 days before the registration date.
•Colonoscopy, Gastrointestinal scopy
•17. Patients who have had, or currently have, a gastrointestinal cancer, excluding gastrointestinal cancer cured by endoscopic treatment
•18. Patients currently suffering from severe cardiovascular, respiratory, renal, hepatic, gastrointestinal (excluding chronic constipation), hematological or neurological / psychiatric disorders.
•19. Patients with a history of drug allergy.
•20. Patients who have participated in or are currently participating in clinical trials, post-marketing clinical trials, clinical studies of other drugs or medical devices within 12 weeks before obtaining consent.
•21. Patients who are considered inappropriate to participate in this study by the reseacher.

研究者

发起方

Yoshihara Tsutomu

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