Status:
COMPLETED
Phase Ⅱ Dose Response Study of NPO-13 in Patients Undergoing Total Colonoscopy
Lead Sponsor:
Nihon Pharmaceutical Co., Ltd
Conditions:
Bowel Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Patients who require screening colonoscopy will receive an intraluminal spraying of NPO-13 per contraction region of large bowel up to fifth times during the colonoscopy. The efficacy of NPO-13 will ...
Eligibility Criteria
Inclusion
- Inpatients or outpatients of either sex who visit medical institutions for treatment or follow-up of confirmed or suspected colonic disease (symptoms) and meet the criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.
- Patients who need colonoscopy
- Patients who are older than 20 years at the time of consent
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
- Patients on cancer treatment (chemotherapy or radiotherapy)
- Patients who need sedative 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 who have been exposed to NPO-13
- Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT02265939
Start Date
October 1 2014
End Date
March 1 2015
Last Update
November 16 2021
Active Locations (3)
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1
Fukuoka, Japan
2
Osaka, Japan
3
Tokyo, Japan