742599
Last Update Posted: 2010-11-09
Recruiting has ended
All Genders accepted | 20 Years + |
80 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy
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.
Eligibility
Relevant conditions:
Patients Undergoing Gastric Endoscopy
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Data sourced from ClinicalTrials.gov