NCT00740324

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nihon Pharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-03-01
• Completion: 2009-07-01
• First posted: 2008-08-22
• Last updated: 2010-11-09

Locations

1 site across 1 country: Japan