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Exploratory Study of Additional Use of Scopolamine Butylbromide, Glucagon or NPO-11 Following Single Dose of NPO-11 in Healthy Adult Men

NCT ID: NCT00740324

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of the additional administration of scopolamine butylbromide, glucagon or NPO-11 following a single intragastric dose of NPO-11 during endoscopy in healthy adult men. The safety will be evaluated based on adverse events and adverse drug reactions (ADRs) observed with NPO-11 + scopolamine butylbromide or glucagon, and following additional administration of NPO-11. The efficacy will be evaluated based on changes in the frequency of gastric peristalsis classification after the initial dose and the additional dose, and on the presence or absence of gastric peristalsis at each evaluation point.

Detailed Description

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Conditions

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Healthy

Keywords

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During Endoscopy Gastric Peristalsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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N

Group Type ACTIVE_COMPARATOR

NPO-11

Intervention Type DRUG

NPO-11 after administration of NPO-11

B

Group Type ACTIVE_COMPARATOR

NPO-11

Intervention Type DRUG

20 mg butylscopolammonium bromide after administration of NPO-11

G

Group Type ACTIVE_COMPARATOR

NPO-11

Intervention Type DRUG

1 mg glucagons after administration of NPO-11

Interventions

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NPO-11

20 mg butylscopolammonium bromide after administration of NPO-11

Intervention Type DRUG

NPO-11

NPO-11 after administration of NPO-11

Intervention Type DRUG

NPO-11

1 mg glucagons after administration of NPO-11

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Healthy adult male volunteers who meet all the following criteria will be enrolled in the study. Subjects have to provide written informed consent for voluntary participation in the study.

1. Volunteers who are in good health as confirmed by the investigator or subinvestigator
2. Volunteers (age from 35 to less than 65 years old at the time of consent)

Exclusion Criteria

Volunteers who meet any of the following criteria will be excluded from the study.

1. Volunteers with any clinically significant symptoms, physical findings or laboratory values at screening visit which are considered unsuitable for participation in the study in the investigator's or subinvestigator's opinion
2. Volunteers with a history of surgery in the upper gastrointestinal tract
3. Volunteers with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
4. Volunteers with a history of shock or hypersensitivity to scopolamine butylbromide, glucagon, lidocaine hydrochloride or heparin sodium
5. Volunteers who are contraindicated for administration of scopolamine butylbromide or glucagon in the investigator's or subinvestigator's opinion based on health interview
6. Volunteers who have been exposed to NPO-11
7. Volunteers who have received other investigational drugs within four months before consent or who are participating in other clinical studies
8. Volunteers otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nihon Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Nihon Pharmaceutical Co., Ltd

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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NPO-11-01/SE-02

Identifier Type: -

Identifier Source: org_study_id