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Clinical Trial 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


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00745459
Study type Interventional
Source Nihon Pharmaceutical Co., Ltd
Contact
Status Completed
Phase Phase 3
Start date September 2008
Completion date August 2009

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