Study of NPO-13 During Colonoscopy
- Conditions
- Bowel Disease
- Registration Number
- NCT04097574
- Lead Sponsor
- Nihon Pharmaceutical Co., Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
- Patients who are between 20 and 85 years at the time of consent
- Patients who need colonoscopy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment 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.
- Secondary Outcome Measures
Name Time Method Change in colonic spasm before and after treatment of NPO-13 treatment 3 minutes The evaluated colonic spasm grades will be converted into a numeric score, and difference between paired mean scores (before and after application, or 0.8% NPO-13, 1.6% NPO-13 and placebo) will be calculated.
Adverse events and Adverse drug reactions 7 ± 3 days The subjects will be observed for 7 days after colonoscopy, and all adverse events and adverse drug reactions will be recorded and compared with the placebo group.
Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment 3 minutes The secondary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe.
Time to effect 3 minutes The onset of anti-spasmodic effect is the interval from the spray to the disappearance of the spasm.
Difficulty of endoscopic observation 3 minutes The proportion of subjects in whom intracolonic examination will be evaluated by the investigator to be "Very easy" or "Easy"., using a four-grade scale: 1, Very easy; 2, Easy; 3, Difficult; 4, Hard.
Trial Locations
- Locations (13)
NPO-13 Trial Site 12
🇯🇵Kurume, Fukuoka, Japan
NPO-13 Trial Site 1
🇯🇵Shimotsuke, Tochigi, Japan
NPO-13 Trial Site 2
🇯🇵Maebashi, Gunma, Japan
NPO-13 Trial Site 6
🇯🇵Yokohama, Kanagawa, Japan
NPO-13 Trial Site 5
🇯🇵Yokohama, Kanagawa, Japan
NPO-13 Trial Site 4
🇯🇵Minato, Tokyo, Japan
NPO-13 Trial Site 3
🇯🇵Shinjuku, Tokyo, Japan
NPO-13 Trial Site 9
🇯🇵Hiroshima, Japan
NPO-13 Trial Site 10
🇯🇵Kochi, Japan
NPO-13 Trial Site 8
🇯🇵Osaka, Japan
NPO-13 Trial Site 7
🇯🇵Osaka, Japan
NPO-13 Trial Site 13
🇯🇵Kagoshima, Japan
NPO-13 Trial Site 11
🇯🇵Kitakyushu, Fukuoka, Japan