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临床试验/jRCTs031200209
jRCTs031200209已完成不适用

Efficacy and safety of Elobixibat as a preparation for colonoscopy: a single-center, open-label, randomized controlled exploratory trial (none)

未提供0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Screening
盲法
Open(masking Not Used)

入排标准

年龄范围
20age old over 至 No limit(—)
性别
All

入选标准

  • •(1) Patients capable of taking oral bowel cleansers who are undergoing colonoscopy.
  • •(2) Patients over 20 years of age at the time of obtaining consent.
  • •(3) Patients who take an oral bowel cleanser in the hospital.
  • •(4) Patients with written consent to participate in this study.
  • •(5) Patients who are able to walk independently and respond to questionnaires and other surveys.

排除标准

  • •(1) Patients with advanced colorectal cancer, extramural compression due to intra-abdominal tumors, Crohn's disease, ischemic colitis, and bowel obstruction.
  • •(2) Patients with previous colorectal resection.
  • •(3) Patients with extremely poor general health, NYHA cardiac function classifications III and IV with severe cardiac disease and renal disease with eGFR<
  • •(4) Patients with significant electrolyte abnormalities with a serum Na concentration of less than 135 mEq/L, 148 mEq/L or greater, or a serum K concentration of less than 3.5 mEq/L or greater than 5.0 mEq/L.
  • •(5) Patients with a history of hypersensitivity to the components of Goofice tablets (elobixibat).
  • •(6) Patients who do not undergo total colorectal observation.
  • •(7) Patients who participated in a drug or other clinical trial at the same time as the study or within 30 days prior to inclusion in the study.
  • •(8) Patients taking Goofice tablets (elobixibat).
  • •(9) Patients who are pregnant, lactating, or who may be pregnant.
  • •(10) Other patients who are deemed unsuitable for inclusion in the subject by the physician.
  • •(11) Patients on the Bristol Stool Form Scale 1 or 2.

结局指标

主要结局

-

Bowel Cleanliness (BBPS)

次要结局

  • Tolerability and satisfaction
  • Any side effects

研究者

发起方
未提供

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