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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: NPO-11; Drug: NPO-11; Drug: NPO-11

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: NPO-11; 20 mg butylscopolammonium bromide after administration of NPO-11; Drug: NPO-11; NPO-11 after administration of NPO-11; Drug: NPO-11; 1 mg glucagons after administration of NPO-11
Active Comparator: G	Drug: NPO-11; 20 mg butylscopolammonium bromide after administration of NPO-11; Drug: NPO-11; NPO-11 after administration of NPO-11; Drug: NPO-11; 1 mg glucagons after administration of NPO-11
Active Comparator: N	Drug: NPO-11; 20 mg butylscopolammonium bromide after administration of NPO-11; Drug: NPO-11; NPO-11 after administration of NPO-11; Drug: NPO-11; 1 mg glucagons after administration of NPO-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
[Safety] (Evaluation by investigator or subinvestigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration	7 ± 3 days after administration

Secondary Outcome Measures

Outcome Measure	Time Frame
[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

Collaborators and Investigators

• Sponsor: Nihon Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: August 21, 2008
• First Submitted That Met QC Criteria: August 21, 2008
• First Posted (Estimate): August 22, 2008

Study Record Updates

• Last Update Posted (Estimate): November 9, 2010
• Last Update Submitted That Met QC Criteria: November 8, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Endoscopy; Gastric; During; Peristalsis
• Other Study ID Numbers: NPO-11-01/SE-02