NCT00742599

Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy

Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Randomized, Double-blind, Parallel-assignment , Placebo-controlled Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Nihon Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Patients who require gastric endoscopy will receive an intragastric single dose of NPO-11 20 mL. The superiority of NPO-11 to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary outcome measure). 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.

Conditions

• Patients Undergoing Gastric Endoscopy

Interventions

Type	Name	Description
DRUG	NPO-11	20 ml NPO-11
DRUG	Placebo	20 ml NPO-11(Placebo)

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-04-01
• Completion: 2009-07-01
• First posted: 2008-08-27
• Last updated: 2010-11-09

Locations

2 sites across 1 country: Japan