NCT03003884

A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (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 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-center,single-blinded,parallel-group,dose-finding study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for propofol).Lidocaine and 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: 2016-11-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-12-28
• Last updated: 2017-09-08

Locations

1 site across 1 country: China