NCT03779061

Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 388 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 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 colonoscopy.

Detailed description

This is a multi-center, parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing colonoscopy.Subjects 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.

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: 2018-06-28
• Primary completion: 2018-09-20
• Completion: 2018-09-28
• First posted: 2018-12-19
• Last updated: 2018-12-19

Locations

1 site across 1 country: China