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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
85
20 mL NPO-11 in a prefilled plastic syringe
The placebo is included same additives as active comparator.
Nihon Pharmaceutical Co., Ltd
Tokyo, Japan
The proportion of patients had no or mild peristalsis during the therapeutic procedures
No or mild gastric peristalsis is defined as when patients have no or suppressed gastric peristalsis during the therapeutic procedure. The degree of gastric peristalsis in the time periods is assessed by an independent committee.
Time frame: 60 minutes
Duration of peristalsis-suppressing effect
Time frame: 60 minutes
Difficulty level of the therapeutic procedure
Time frame: 60 minutes
One-piece resection rate with tumor-free margin
Time frame: 60 minutes
Adverse events and adverse drug reactions
Time frame: 7 days
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