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

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

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Key information

Conditions

Stomach Diseases Digestive System Diseases Gastrointestinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chūbu, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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 Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.

Patients with a history of surgery to the stomach
Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
Patients with upper gastrointestinal bleeding which requires hemostasis
Patients on cancer treatment (chemotherapy or radiotherapy)
Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
Patients with a history of shock or hypersensitivity to lidocaine hydrochloride
Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
Patients who have been exposed to NPO-11
Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion

Treatment and study plan

NPO-11

Drug

20 mL NPO-11

Primary outcomes

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.

Time frame: each evaluation point

Secondary outcomes

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

Time frame: each evaluation point

Sponsors and collaborators

Lead sponsor

Nihon Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Open-label Study)

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Sep 3, 2008
Registry last updated: Nov 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed