Phase III Placebo-controlled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy (Randomized, Double-blind, Parallel-assignment, Placebo-controlled Study)
Inclusion Criteria:
inpatients or outpatients of either sex who require therapeutic upper gastrointestinal
endoscopy (EMR or ESD) and meet the criteria (1)-(4) below will be enrolled in the study.
Patients have to provide written informed consent for voluntary participation in the
study. The criteria (2) and (3) will be confirmed by the endoscopic observation just
before starting the intended treatment.
1. Patients with an early gastric cancer located in the lower third of the stomach, who
require therapeutic upper gastrointestinal endoscopy (EMR or ESD) (except for those
with an intended treatment by using a scope of <9 mm in diameter)
2. Differentiated -type intramucosal gastric cancer or the suspected lesion, ≤ 2 cm in
size, no ulcer finding
3. Patients with a single intended lesion for the treatment
4. Patients who are older than 20 years at the time of consent
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study
beforehand. The criteria (3) to (5) will be confirmed by the endoscopic observation just
before starting the intended treatment.
1. Patients with a history of surgery to the upper gastrointestinal tract
2. Patients who require emergency endoscopy
3. Patients with severe gastric stenosis or deformation which makes observation of
gastric peristalsis difficult
4. Patients who require emergency endoscopic treatment except for the intended lesion
5. Patients with a lesion extended to the pyloric ring
6. Patients with an ongoing cancer treatment (chemotherapy or radiotherapy)
7. Patients with pacemaker
8. Patients with known bleeding tendency or Patients with difficulty of antithrombogenic
agents withdrawal
9. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil
10. Patients with contraindications to glucagon
11. Patients with contraindications to benzodiazepines, pethidine hydrochloride, and
epinephrine
12. Pregnant or lactating women, women of childbearing potential, or women who plan to
become pregnant during the study
13. Patients who have received other investigational drugs within four months before
consent or who are participating in other clinical studies
14. Patients otherwise ineligible for participation in the study in the investigator's
opinion