Clinical trial NCT00745459: Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy
Official title: Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Open-label Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stomach Diseases
Keywords: Patients
undergoing
gastric
endoscopy
Lead sponsor: Nihon Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who require gastric endoscopy, including the patient population\* excluded from the phase III controlled clinical study of NPO-11, will receive an intragastric single dose of NPO-11 20 mL. The efficacy of NPO-11 as a premedication for endoscopy will be evaluated 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.

Patient population excluded from the phase III controlled clinical study of NPO-11

* Patients with reflux esophagitis
* Patients with active gastric or duodenal ulcers
* Patients who undergo endoscopy under sedation
* Patients who undergo endoscopy with a scope of \<9 mm in diameter


Eligibility criteria: Inclusion Criteria:

Inpatients or outpatients of either sex who meet criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.

1. Patients who require gastric endoscopy (except for emergency endoscopy or endoscopy for comprehensive medical examination)
2. 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. The criteria (2) and (3) will be confirmed during endoscopy. Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.

1. Patients with a history of surgery to the stomach
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 on cancer treatment (chemotherapy or radiotherapy)
5. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
6. Patients with a history of shock or hypersensitivity to lidocaine hydrochloride
7. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
8. Patients who have been exposed to NPO-11
9. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
10. Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion

Primary outcomes:
measure: Presence or absence of gastric peristalsis (central evaluation by independent evaluator) No gastric peristalsis is defined as when patients have no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy.
timeFrame: each evaluation point
Secondary outcomes:
measure: Change in gastric peristalsis (central evaluation by independent evaluator) Difficulty level of intragastric observation (evaluation by investigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration
timeFrame: each evaluation point
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Shikoku
country: Japan
Study officials:
References: