Phase II exploratory study of NPO-13 in patients undergoing colonoscopy

Nihon Pharmaceutical Co., Ltd1 个研究点目标入组 150 人开始时间: 待定最近更新: 2022年11月28日

试验速览

暂无简介。

研究类型: Interventional
干预模型: Placebo Control, Randomized, Double-Blind, Multi-center, Parallel Assignment Study
主要目的: Diagnostic Purpose

•(1) Patients with a history of abdominal surgical treatment (including the laparoscopic surgery) including the gynecology operation
•(2) Patients with contraindication to colonoscopy including the paralytic ileus
•(3) Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
•(4) Patient with contraindication to bowel cleansing preparation
•(5) Patient with contraindication to pain medicine and sedative medicine
•(6) Patient with contraindication to butylscopolamine bromide and glucagon
•(7) Patients on cancer treatment (chemotherapy or radiotherapy)
•(8) Patient with active inflammatory bowel disease or infectious enteritis
•(9) Patients who need sedative in colonoscopy
•(10) Patients who receives a therapeutic colonoscopy
•(11) Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
•(12) Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
•(13) Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion

efficacy exploratory Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment

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发起方

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