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

NCT00745459 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-11-09

No results posted yet for this study

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

DRUG

NPO-11

20 mL NPO-11

Sponsors & Collaborators

  • Nihon Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-04-30
Completion
2009-08-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00745459 on ClinicalTrials.gov