NCT01411189

Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Nihon Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Patients who require therapeutic upper gastrointestinal endoscopy, such as polypectomy, endoscopic hemostasis, percutaneous endoscopic gastrostomy (PEG), endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive an intragastric spraying of NPO-11. The efficacy of NPO-11 as an anti-peristaltic agent for the endoscopic therapeutic procedures will be evaluated based on the proportion of patients with suppressed gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by an independent committee. 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.

Conditions

• Gastric Cancer
• Colon Nos Polypectomy Tubular Adenoma
• Gastric Adenoma

Interventions

Type	Name	Description
DRUG	Menthol	20 mL NPO-11 in prefilled syringe

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2011-08-08
• Last updated: 2012-06-29

Locations

1 site across 1 country: Japan