Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 4:08 PM
Study NCT ID:
NCT00745459
Status:
COMPLETED
Last Update Posted:
2010-11-09
First Post:
2008-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy
Sponsor:
Nihon Pharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy (Open-label Study)
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: