Phase III Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
Patients with early gastric cancer, who require therapeutic upper gastrointestinal endoscopy,
such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will
receive intragastric spraying of NPO-11 or placebo. The superiority of NPO-11 to placebo as
anti-peristaltic agent will be verified in a randomized, double-blind, parallel-assignment
design 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 in comparison with
the placebo group.