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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
20 mL NPO-11 in prefilled syringe
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 (for 45 s). 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
Adverse events and adverse drug reactions
Time frame: 7 days
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