Stomach Diseases Clinical Trial
Official title:
Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Open-label Study)
Patients who require gastric endoscopy, including the patient population* excluded from the
phase III controlled clinical study of NPO-11, will receive an intragastric single dose of
NPO-11 20 mL. The efficacy of NPO-11 as a premedication for endoscopy will be evaluated
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.
Patient population excluded from the phase III controlled clinical study of NPO-11
- Patients with reflux esophagitis
- Patients with active gastric or duodenal ulcers
- Patients who undergo endoscopy under sedation
- Patients who undergo endoscopy with a scope of <9 mm in diameter
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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