Viewing Study NCT03779061



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Last Modification Date: 2024-10-26 @ 1:00 PM
Study NCT ID: NCT03779061
Status: COMPLETED
Last Update Posted: 2018-12-19
First Post: 2018-12-16

Brief Title: Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy
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 Colonoscopy
Status: COMPLETED
Status Verified Date: 2018-07
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 colonoscopy
Detailed Description: This is a multi-center parallel-group single blind study using Remimazolam or propofol for sedation in patients undergoing colonoscopySubjects are randomized to different treatment groups including 1 for Remimazolam Tosilate and 1 for propofol Fentanyl are permitted before colonoscopy Efficacy 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