Patients Undergoing Gastric Endoscopy Clinical Trial
Official title:
Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Randomized, Double-blind, Parallel-assignment , Placebo-controlled Study)
Patients who require gastric endoscopy will receive an intragastric single dose of NPO-11 20
mL. The superiority of NPO-11 to placebo as a premedication for endoscopy will be verified
in a randomized, double-blind, parallel-assignment design based on the percentage of
patients having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy
(primary outcome measure).
The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions
(ADRs) observed between administration and seven days after administration in comparison
with the placebo group.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment