NCT03425474

Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 endoscopy.Subjects are randomized to different treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	Remimazolam Tosilate	Initial dose plus supplemental doses as necessary
DRUG	Propofol	Initial dose plus supplemental doses as necessary

Timeline

• Start date: 2017-09-01
• Primary completion: 2017-11-10
• Completion: 2017-11-10
• First posted: 2018-02-07
• Last updated: 2018-02-12

Locations

1 site across 1 country: China