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Patients Undergoing Gastric Endoscopy

Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy

Sponsored by Nihon Pharmaceutical Co., Ltd

About this trial

Last updated 15 years ago

Study ID

NPO-11-01/C-01

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
20+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 16 years ago

What is this trial about?

Patients who require gastric endoscopy will receive an intragastric single dose of NPO-11 20 mL. The superiority of NPO-11 to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary outcome measure). 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.

What are the participation requirements?

Yes

Inclusion Criteria

1. Patients who need gastric endoscopy (except for endoscopy with a scope of <9 mm in diameter, emergency endoscopy and endoscopy for comprehensive medical examination)

2. Patients who are older than 20 years at the time of consent

No

Exclusion Criteria

1. Patients with a history of surgery to the upper gastrointestinal tract

2. Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult

3. Patients with upper gastrointestinal bleeding which requires hemostasis

4. Patients with reflux esophagitis (Los Angeles classification: B, C or D)

5. Patients with gastric or duodenal ulcers in active stage

6. Patients on cancer treatment (chemotherapy or radiotherapy)

7. Patients with impaired cardiac function (NYHA functional classification: III or IV)

8. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)

9. Patients with a history of shock or hypersensitivity to lidocaine hydrochloride

10. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study

11. Patients who have been exposed to NPO-11

12. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies

13. Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion