Ignite Creation Date:
2024-05-06 @ 9:32 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT03003884
Status:
COMPLETED
Last Update Posted:
2017-09-08
First Post:
2016-12-22
Brief Title:
A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-12
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:
The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and safety profile comparing to propofol
Detailed Description:
This is an multi-centersingle-blindedparallel-groupdose-finding study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopySubjects are randomized to different treatment groups including 4 for Remimazolam Tosilate and 1 for propofolLidocaine and fentanyl are permitted during a diagnostic upper GI endoscopyEfficacy and safety profiles of Remimazolam Tosilate are to be evaluated
Study Oversight
Has Oversight DMC:
None
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?:
None