NCT03263910已完成3 期
Phase Ⅲ Placebo-controlled Study of NPO-11 in Chinese Patients Undergoing Gastrointestinal Endoscopy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The proportion of patients had no gastric peristalsis during the procedures
研究概览
简要总结
Chinese patients who require gastrointestinal endoscopy will receive an intra-gastric single dose of NPO-11 20ml. The superiority of NPO-11 compared to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients having no gastric peristalsis.
The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions observed between informed consent and 7 days after administration in comparison with the placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are capable of understanding and complying with protocol requirements in the opinion of the investigator or the sub-investigator.
- •Patients who are able to fill in the informed consent form.
- •Patients who require gastrointestinal endoscopy using a scope of 9mm or greater diameter for follow-up of confirmed or investigation of a suspected upper gastrointestinal disease. (except for transnasal endoscopy and emergency endoscopy)
- •Male or female chinese patients aged _18_ to _80
- •Patients who agree to use routinely adequate contraception from signing of informed consent to follow-up.
排除标准
- •Patients have received any investigational drug of other study within 120 days prior to providing their informed consent.
- •Patients had been administered NPO-11 in the past.
- •Patients who are the study site investigator or sub-investigator, an immediate family member (eg, spouse,parent, child, sibling), or may consent under duress.
- •Patients have a history of upper gastrointestinal tract surgery.
- •Patients have gastric stenosis or deformity that would make observation of peristaltic movement difficult.
- •Patients have bleeding in the upper gastrointestinal tract and require hemostatic intervention.
- •Patients have reflux esophagitis (defined as Los Angeles Class: B, C or D)
- •Patients have an active gastric or duodenal ulcer (defined as Sakita-Miwa class: A1 or A2)
- •Patients are on treatment (radiotherapy or chemotherapy) for cancer.
- •Patient have decreased heart function (NYHA heart function class: III or more)
- •Patients have a history of shock, hypersensitivity or allergies to l-menthol or peppermint oil.
- •Patients have a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 12 months prior to the screening visit.
- •Patients are required to take excluded medications.
- •If female, patients are pregnant or lactating or intending to become pregnant from signing of informed consent to follow-up.
- •Any subject who, in the opinion of the investigator or the sub-investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.
研究组 & 干预措施
NPO-11
Experimental
干预措施: NPO-11 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of patients had no gastric peristalsis during the procedures
时间窗: 15 minutes
No gastric peristalsis is defined as when patients have no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy.(central evaluation by independent evaluator)
次要结局
- Change in peristaltic movement(15 minutes)
- Difficulty level of intra-gastric observation(15 minutes)
- Correlation between the time from the dose to the end of endoscopy and peristaltic grade(15 minutes)
研究者
研究点 (1)
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