Gastric Cancer Clinical Trial
Official title:
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
Patients who require therapeutic upper gastrointestinal endoscopy, such as polypectomy,
endoscopic hemostasis, percutaneous endoscopic gastrostomy (PEG), endoscopic mucosal
resection (EMR) and endoscopic submucosal dissection (ESD), will receive an intragastric
spraying of NPO-11. The efficacy of NPO-11 as an anti-peristaltic agent for the endoscopic
therapeutic procedures will be evaluated based on the proportion of patients with suppressed
gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by
an independent committee.
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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