NCT04097574已完成2 期
Phase II Study of NPO-13 in Patients Undergoing Colonoscopy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 13
- 主要终点
- Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment
研究概览
简要总结
This study will investigate the safety, efficacy and dose-response of NPO-13 in subjects with moderate to severe colonic spasm during colonoscopy. An intraluminal spraying of NPO-13 dosed up to twice into ascending or sigmoid colon. The colonic spasm will be assessed by an independent committee using recorded video images. The study consists of a screening visit window, 1-day treatment phase and 1-week follow-up phase.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are between 20 and 85 years at the time of consent
- •Patients who need colonoscopy
排除标准
- •Patients with a history of abdominal surgical treatment (including the laparoscopic surgery) including the gynecology operation
- •Patients with contraindication to colonoscopy including the paralytic ileus
- •Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
- •Patient with contraindication to bowel cleansing preparation
- •Patient with contraindication to pain medicine and sedative medicine
- •Patient with contraindication to butylscopolamine bromide and glucagon
- •Patients on cancer treatment (chemotherapy or radiotherapy)
- •Patient with active inflammatory bowel disease or infectious enteritis
- •Patients who need sedative in colonoscopy
- •Patients who receives a therapeutic colonoscopy
- •Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
- •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 coinvestigator's opinion
研究组 & 干预措施
NPO-13 0.8%
Active Comparator
Low dose
干预措施: NPO-13: l-menthol (Drug)
NPO-13 1.6%
Active Comparator
High dose
干预措施: NPO-13: l-menthol (Drug)
NPO-13 0%
Placebo Comparator
Placebo
干预措施: NPO-13: l-menthol (Drug)
结局指标
主要结局
Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment
时间窗: 3 minutes
The primary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe.
次要结局
- Change in colonic spasm before and after treatment of NPO-13 treatment(3 minutes)
- Adverse events and Adverse drug reactions(7 ± 3 days)
- Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment(3 minutes)
- Time to effect(3 minutes)
- Difficulty of endoscopic observation(3 minutes)
研究者
研究点 (13)
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