NCT00745459

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

Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Open-label Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Nihon Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Patients who require gastric endoscopy, including the patient population\* excluded from the phase III controlled clinical study of NPO-11, will receive an intragastric single dose of NPO-11 20 mL. The efficacy of NPO-11 as a premedication for endoscopy will be evaluated 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. Patient population excluded from the phase III controlled clinical study of NPO-11 * Patients with reflux esophagitis * Patients with active gastric or duodenal ulcers * Patients who undergo endoscopy under sedation * Patients who undergo endoscopy with a scope of \<9 mm in diameter

Conditions

• Stomach Diseases

Interventions

Type	Name	Description
DRUG	NPO-11	20 mL NPO-11

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-04-01
• Completion: 2009-08-01
• First posted: 2008-09-03
• Last updated: 2010-11-09

Locations

4 sites across 1 country: Japan