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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
132
Unnamed facility
Fukuoka, Japan
Unnamed facility
Osaka, Japan
Unnamed facility
Tokyo, Japan
The proportion of the splayed region with no contraction after NPO-13 dosage
Time frame: 3 min
The proportion of the splayed region with an onset of action
Time frame: 3 min
The proportion of patients with no contraction in all the sprayed regions
Time frame: 3 min
The proportion of patients with no contraction in one or more the sprayed region
Time frame: 3 min
Change in colonic contraction
Time frame: 3 min
Adverse events and ADRs observed between administration and 7 ± 3 days after administration
Time frame: up to 10 days
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