Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Open-label Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Presence or absence of gastric peristalsis (central evaluation by independent evaluator) No gastric peristalsis is defined as when patients have no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy.
研究概览
简要总结
Patients who require gastric endoscopy, including the patient population* excluded from the phase III controlled clinical study of NPO-11, will receive an intragastric single dose of NPO-11 20 mL. The efficacy of NPO-11 as a premedication for endoscopy will be evaluated based on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary outcome measure).
The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.
Patient population excluded from the phase III controlled clinical study of NPO-11
- Patients with reflux esophagitis
- Patients with active gastric or duodenal ulcers
- Patients who undergo endoscopy under sedation
- Patients who undergo endoscopy with a scope of <9 mm in diameter
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
- •Inpatients or outpatients of either sex who meet criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.
- •Patients who require gastric endoscopy (except for emergency endoscopy or endoscopy for comprehensive medical examination)
- •Patients who are older than 20 years at the time of consent
排除标准
- •Patients who meet any of the following criteria will be excluded from the study. The criteria (2) and (3) will be confirmed during endoscopy. Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.
- •Patients with a history of surgery to the stomach
- •Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
- •Patients with upper gastrointestinal bleeding which requires hemostasis
- •Patients on cancer treatment (chemotherapy or radiotherapy)
- •Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
- •Patients with a history of shock or hypersensitivity to lidocaine hydrochloride
- •Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
- •Patients who have been exposed to NPO-11
- •Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
- •Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
研究组 & 干预措施
N
20 mL NPO-11
干预措施: NPO-11 (Drug)
结局指标
主要结局
Presence or absence of gastric peristalsis (central evaluation by independent evaluator) No gastric peristalsis is defined as when patients have no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy.
时间窗: each evaluation point
次要结局
- Change in gastric peristalsis (central evaluation by independent evaluator) Difficulty level of intragastric observation (evaluation by investigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration(each evaluation point)