JPRN-jRCTs061200030已完成未知
Single-center, randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effects of Elobixibat on rectal sensory threshold in patients with chronic constipation over 60 years of age
Manabe Noriaki0 个研究点目标入组 30 人开始时间: 2020年12月1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
- 30
研究概览
简要总结
Administration of patients with chronic constipation with elobixibat decreased the rectal sensory threshold and increased stool bile acids, suggesting that it may improve rectal sensation.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 60age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Subjects who meet every those following criteria.
- •Patients with chronic constipation:
- •1)Patients who meet every those following criteria
- •Subjects who have had subjective symptoms of chronic constipation for more than 6 months and have met the following criteria for the last 3 months.
- •1. There are two or more of the following symptoms.
- •-Straining among more than 25% of defecations.
- •-Feeling of obstruction or a feeling of fullness of the rectal anus more than 25% of defecations.
- •-Scybalum or hard stool among more than 25% of defecations.
- •-Manual maneuvers to facilitate more than 25% of defecations (stool extraction, Oppression the pelvic floor, etc.).
- •-Feeling of unsatisfied defecation among more than 25% of defecations.
- •-Defecation less than three times a week.
- •2. Soft stool rarely occurs when laxatives are not used.
- •3. Does not meet the criteria for irritable bowel syndrome (IBS).
- •2) Age : Over 60 years at the time of informed consent.
- •3) Ability to provide written informed consent.
- •Healthy adult subjects :
- •1) Subjects who have bowel movements almost every day from more than 6 months prior to informed consent.
- •2) Age : Over 60 years at the time of informed consent
- •3) Ability to provide written informed consent
- •4) No comorbidities
排除标准
- •Subjects who meet any of the following criteria are not included.
- •Patients with chronic constipation:
- •1) Patients with or suspected organic constipation, outlet obstruction type constipation
- •2) Patients with suspected biliary obstruction or decreased bile secretion
- •3) Patients who not able to use rescue medication (Bisacodyl suppositories 10 mg)
- •4) Patients with malignant tumor
- •5) Patients with a medical history of hypersensitivity to Elobixibat.
- •6) Patients who are taking bile acid preparations (ursodeoxycholic acid, chenodeoxycholic acid), aluminum-containing preparations (sucralfate hydrate, aldioxa, etc.), cholestyramine, colestimide, digoxin, Dabigatran etexilate methanesulfonate, or midazolam
- •7) Patients who were considered as ineligible by the investigator/sub-investigator for any other reasons
- •8) Patients who have serious disease related to the kidney (creatinine>=2.00 mg/dL)or the liver (total bilirubin >=3.0 mg/dL or AST or ALT >=100 U/L) or the heart at the time of Visit-1
- •9) Patients who used the rescue medication(Bisacodyl suppositories 10 mg) over three times during the 1-week observation period
- •10) Patients who used the rescue medication less than 72 hours after bowel movement during the 1-week observation period
- •11) Patients with soft stool or watery stool (Bristol Stool Form Scale type 6 or 7) due to spontaneous evacuation of stool, during the 1-week observation period
- •12)Patients who used prohibited medications and prohibited therapies during the 1-week observation period
- •Healthy adult subjects :
- •1) Subjects who have serious disease related to the kidney (creatinine>=2.00 mg/dL)or the liver (total bilirubin >=3.0 mg/dL or AST or ALT >=100 U/L) or the heart at inspection within the past 1 year
- •2) Subjects who were considered as ineligible by the investigator/sub-investigator for any other reasons
- •3) Subjects who recorded at least twice soft stool or watery stool (Bristol Stool Form Scale type 6 or 7) due to spontaneous evacuation of stool, during the 1-week observation period
- •4) Subjects who have fewer than 5 bowel movements during the 1-week observation period
研究者
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