Phase Ⅱ Dose Response Study of NPO-13 in Patients Undergoing Total Colonoscopy
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
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 be evaluated based on the proportion of the splayed region with
no contraction after NPO-13 dosage (primary outcome measure). The colonic spasm will be
assessed by an independent committee using recorded video images.
The safety of NPO-13 will be evaluated based on adverse events and adverse drug reactions
(ADRs) observed between administration and seven days after administration.