NCT05703464终止4 期
A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of change in loss of defecation desire
研究概览
简要总结
Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of provisional registration
- •Patients diagnosed with chronic constipation using the Rome IV criteria for the diagnosis of chronic constipation
- •Age: 20 years or older (at the time of obtaining consent)
- •Gender: Any
- •outpatients
- •Patients for whom written consent can be obtained
- •Patients who can record defecation, etc. in the patient diary
- •At the time of registration ・ Dosing start criteria Patients with the following ・'Loss of defecation desire'* in the second week of the observation period (1 week before the start of the treatment period)
- •*"Loss of defecation desire " refers to patients whose "presence or absence of defecation desire" on the patient questionnaire was "
- •almost never" or "
排除标准
- •At the time of temporary registration Exclude patients with any of the following conditions
- •Patients with organ-related constipation or suspected of having organ-related constipation
- •Patients with or suspected of having functional ileus
- •Patients with or suspected of having inguinal hernia
- •Patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection)
- •Patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy
- •Patients with complications of malignancy However, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered.
- •Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study
- •Patients with serious renal, hepatic, or cardiac disease
- •Patients with drug allergy to the study drug
- •Patients who are participating in other clinical studies, or who have participated in other clinical studies within 4 weeks prior to obtaining consent However, observational studies are excluded.
- •Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study.
- •At the time of registration、Dosing start criteria
- •Patients who increased the dose of concomitantly restricted drugs during the observation period
- •Patients who used concomitantly prohibited drugs during the observation period
研究组 & 干预措施
Elobixibat
Experimental
10mg Elobixibat administration for 4 weeks
干预措施: Elobixibat 10mg (Drug)
结局指标
主要结局
Percentage of change in loss of defecation desire
时间窗: Week 4
Percentage of change in loss of defecation desire in the fourth week of the treatment period from the second week of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.
次要结局
- Presence of defecation desire(Week 4)
- Satisfaction with defecation desire(Week 4)
- Satisfaction of straining(Week 4)
- Presence of a sense of incomplete evacuation(Week 4)
- Complete Spontaneous Bowel Movement (CSBM) frequency(Week 4)
- Satisfaction with treatment(Week 4)
- Degree of straining(Week 4)
- Spontaneous bowel movement (SBM) frequency(Week 4)
- Stool hardness based on the Bristol Stool Form Scale(Week 4)
- Constipation severity score(Week 4)
- Japanese version of the Patient Assessment of Constipation Quality of Life(Week 4)
- Change in defecation time.(Week 4)
- Change of bile acid concentration(Week 4)
研究者
Takaomi Kessoku
MD, PhD
International University of Health and Welfare
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Elobixibat for Chronic Constipation Without Defecation DesireChronic ConstipationNCT05165199Yokohama City University40
已完成
不适用
Effects of Elobixibat in patients with diabetes and chronic constipatiopatients with diabetes complicated with chronic constipationJPRN-jRCTs031190092Sone Masakatsu46
终止
3 期
26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic ConstipationChronic Idiopathic ConstipationNCT01827592Ferring Pharmaceuticals376
已完成
不适用
Effects of Elobixibat on rectal visceral perception in constipated patients over 60 years of agechronic constipationJPRN-jRCTs061200030Manabe Noriaki30
已完成
不适用
Efficacy and safety of elobixibat in psychiatric disorders patients with chronic constipation -Retrospective observation researchPsychiatric disorders patients with chronic constipationJPRN-UMIN000042139agisa clinic28