Phase II study of NPO-13 during colonoscopy
- Conditions
- Patients who receive colonoscopy
- Registration Number
- jRCT2080224838
- Lead Sponsor
- Nihon Pharmaceutical Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 150
(1) Patients who are between 20 and 85 years at the time of consent (2) Patients who need colonoscopy
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Placebo Control, Randomized, Double-Blind, Multi-center, Parallel Assignment Study
- Primary Outcome Measures
Name Time Method - efficacy
exploratory
Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Japan
Location not specified
Japan