JPRN-jRCTs071190055已完成未知
A single-center, open-label, single-arm, before and after comparison study to investigate the effects of Elobixibat administration in patients with heart failure complicated with chronic constipation
Tsujita Kenichi0 个研究点目标入组 50 人开始时间: 2020年3月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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 ot applicable（—）
- 性别
- All
入选标准
- •Patients with chronic constipation who meet every those following criteria
- •(At the time of registration(enrollment))
- •1.Patients with chronic constipation who meet every those following criteria
- •1) Meet 2 or more of the following six items
- •a. Straining during more than one-fourth (25%) of defections
- •b. Lumpy or hard stools (BSFS 1-2) more than one-fourth (25%) of defections
- •c. Sensation of incomplete evacuation more than one-fourth (25%) of defections
- •d. Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defections
- •e. Manual maneuvers to facilitate more than one-fourth (25%) of defections (eg, digital evacuation, support of the pelvic floor)
- •f. Fewer than 3 spontaneous bowel movement per week
- •2) Meet every those following 3 items
- •a. Rare to have loose stools without using laxtive
- •b. Never been given diagnosis as irriable bowel syndrome
- •c. Symptoms have been oresent since more than 6 months and meet the criteria 1.-1) for last 3 months..
- •2.Outpatients with stable heart failure who meet every those following criteria
- •1) Classification of NYHA cardiac function is belong to II or III.
- •2) No change in any prescription for heart failure within 12 weeks before obtaining Informed Consent
- •3) No hospitalization history for heart disease treatment within 6 months before obtaining Informed Consent
- •4) Patients judged by doctors to be able to observe during the pre-observation and administration period
- •3.Male and female over 20 years old at the date of Informed Consent
- •4.Patients who are given sufficient description about participation in this study and sufficiently understand it, providing their consent in document by their own free will
- •5.Patients who can write a defecation diary during the study period
排除标准
- •Patients who is applicable those followings to be excluded
- •(At the time of registration(enrollment), at theVisit 2)
- •1.Patients with a history of hypersensitivity to Elobixibat
- •2.Patients with confirmed or suspected bowel obstruction due to tumor, hernia, etc.
- •3.Patients with severe hepatopathy (AST or ALT is 3 times or more for upper limit of in-hospital standard.)
- •4.Patients to be suspected of having biliary atresia or a reducing secretion of bile acid
- •5.Patients suspected of organic constipation
- •6.Female patients who are pregnant, breastfeeding, or hope to raise children
- •7.Patients who are taking bile acid preparations (ursodeoxycholic acid, chenodeoxycholic acid), aluminum-containing preparations (sucralfate hydrate, aldioxa, etc.), cholestyramine, colestimide or midazolam
- •8.Patients who are judged to be ineligible for this research by investigator because of threatening the safety or poor protocol compliance
- •(At the Visit 2)
- •9.Patients who have taken Elobixibat during the previous observation period
研究者
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