745459
Last Update Posted: 2010-11-09
Recruiting has ended
All Genders accepted | 20 Years + |
100 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy
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
Eligibility
Relevant conditions:
Stomach Diseases
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.
locations
Data sourced from ClinicalTrials.gov