jRCT2080224608已完成3 期
A Phase III Comparison Study of NPF-08 in Patients Who Receive Colonoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 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
- 干预模型
- Active-controlled, randomized, endoscopist/imaging rater-blinded, multicenter, parallel-group study
- 主要目的
- Other
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Japanese men and women aged 20 years or older at obtaining the written informed consent.
- •Patients who require colonoscopy(except for emergency colonoscopy).
- •Patients who have the ability to consent and submit the written informed consent by themselves.
排除标准
- •Patients who have or are suspected to have gastrointestinal obstruction.
- •Patients who have or are suspected to have intestinal perforation.
- •Patients who have or are suspected to have toxic megacolon.
- •Patients who have or are suspected to have gastric evacuation disorder (gastroparesis).
- •Patients with intestinal stenosis or high-grade constipation (stool frequency of 2 or less in a week or who have used laxative on a daily basis).
- •Patients with vomiting reflex or in whom accidental ingestion may occur.
- •Patients with a history of gastrointestinal surgery (except for appendicectomy).
- •Patients who were decided as glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
- •Patients with renal impairment (urea nitrogen: 25mg/dL or more, or creatinine: 2mg/dL or more)
- •Patients with hepatic dysfunction (total bilirubin: 3.0mg/dL or more, ALT: 100IU/L or more or AST: 100IU/L or more)
- •Patients who have undergone or require therapy due to high-grade cardiac disease (including angina pectoris or myocardial infarction)
- •Patients with high risk of arrhythmia (with a history or complications of QT prolongation, myocardial infarction, angina pectoris, cardiac failure or cardiomyopathy)
- •Patients with dehydration.
- •Patients who were diagnosed with active inflammatory bowel disease at screening period.
- •Inpatients due to the reasons other than endoscopy large bowel.
- •Patients who have undergone nutritional control using total parenteral nutrition or enteral nutrition.
- •Women who are or may be pregnant, lactating or wish to become pregnant during the trial period.
- •Patients with a history or high-risk of seizure.
- •Patients with a history of shock or hypersensitivity for the active ingredient of the investigational product.
- •Patients who have received the other investigational product within 4 months before the written informed consent or who are participating in the other clinical trials.
- •Patients in whom Investigator/Sub-Investigator decided not to be eligible for this trial.
结局指标
主要结局
-
efficacy The efficacy rate of overall intestinal cleansing effect
次要结局
- Colon cleansing degree by site(Time from the initiation of dosing the investigational product to the completion of colon cleansing on the day of endoscopy)
研究者
研究点 (1)
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