Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03425474
Status:
COMPLETED
Last Update Posted:
2018-02-12
First Post:
2017-09-16
Brief Title:
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:
A Phase Ⅲ Multicentre Randomized Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Diagnostic Upper GI Endoscopy
Status:
COMPLETED
Status Verified Date:
2018-02
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 evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing diagnostic upper GI endoscopy
Detailed Description:
This is a multi-center parallel-group single blind study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopySubjects are randomized to different treatment groups including 1 for Remimazolam Tosilate and 1 for propofol 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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None