MedDataX Logo

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

NCT ID: NCT00742599

Last Updated: 2010-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients Undergoing Gastric Endoscopy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Stomach Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

N

Group Type ACTIVE_COMPARATOR

NPO-11

Intervention Type DRUG

20 ml NPO-11

P

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

20 ml NPO-11(Placebo)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NPO-11

20 ml NPO-11

Intervention Type DRUG

Placebo

20 ml NPO-11(Placebo)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inpatients or outpatients of either sex who visit medical institutions for treatment or follow-up of confirmed or suspected upper gastrointestinal disease (symptoms) and meet the 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 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

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from the study. The criteria (2) to (5) 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 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nihon Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nihon Pharmaceutical Co., Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kansai, , Japan

Site Status

Kanto, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

Hiki N, Kaminishi M, Yasuda K, Uedo N, Honjo H, Matsuhashi N, Hiratsuka T, Sekine C, Nomura S, Yahagi N, Tajiri H, Suzuki H. Antiperistaltic effect and safety of L-menthol sprayed on the gastric mucosa for upper GI endoscopy: a phase III, multicenter, randomized, double-blind, placebo-controlled study. Gastrointest Endosc. 2011 May;73(5):932-41. doi: 10.1016/j.gie.2010.12.013. Epub 2011 Feb 26.

Reference Type DERIVED
PMID: 21353674 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NPO-11-01/C-01

Identifier Type: -

Identifier Source: org_study_id