Status:
COMPLETED
Study of NPO-13 During Colonoscopy
Lead Sponsor:
Nihon Pharmaceutical Co., Ltd
Conditions:
Bowel Disease
Eligibility:
All Genders
20-85 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Patients who are between 20 and 85 years at the time of consent
- Patients who need colonoscopy
Exclusion
- 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
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2020
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT04097574
Start Date
August 26 2019
End Date
March 26 2020
Last Update
August 17 2020
Active Locations (13)
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1
NPO-13 Trial Site 11
Kitakyushu, Fukuoka, Japan
2
NPO-13 Trial Site 12
Kurume, Fukuoka, Japan
3
NPO-13 Trial Site 2
Maebashi, Gunma, Japan
4
NPO-13 Trial Site 5
Yokohama, Kanagawa, Japan