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Phase III Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

NCT ID: NCT01411176

Last Updated: 2012-06-29

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-06-30

Brief Summary

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Patients with early gastric cancer, who require therapeutic upper gastrointestinal endoscopy, such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive intragastric spraying of NPO-11 or placebo. The superiority of NPO-11 to placebo as anti-peristaltic agent will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients with suppressed gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by an independent committee.

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

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Conditions

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Gastric Cancer

Keywords

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upper gastrointestinal endoscopy suspected gastric cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Menthol

20 ml NPO-11

Group Type ACTIVE_COMPARATOR

Menthol

Intervention Type DRUG

20 mL NPO-11 in a prefilled plastic syringe

Placebo

20 ml NPO-11(Placebo)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo is included same additives as active comparator.

Interventions

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Menthol

20 mL NPO-11 in a prefilled plastic syringe

Intervention Type DRUG

Placebo

The placebo is included same additives as active comparator.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nihon Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nihon Pharmaceutical Co., Ltd

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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NPO-11-02/C-02

Identifier Type: -

Identifier Source: org_study_id