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
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