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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740324
• Other study ID #: NPO-11-01/SE-02
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2008
• Last updated: November 8, 2010
• Start date: August 2008
• Est. completion date: July 2009

Study information

• Verified date: November 2010
• Source: Nihon Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• NPO-11
20 mg butylscopolammonium bromide after administration of NPO-11
• NPO-11
NPO-11 after administration of NPO-11
• NPO-11
1 mg glucagons after administration of NPO-11

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nihon Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[Safety] (Evaluation by investigator or subinvestigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration		7 ± 3 days after administration	Yes
Secondary	[Efficacy] (Central evaluation by independent evaluator) (1) Change in the frequency of gastric peristalsis classification (2) Presence or absence of gastric peristalsis at each evaluation point		each evaluation point	No