NCT04470128

A Study Evaluating the Efficacy and Safety of HSK21542 Injection for Analgesia in Subjects Undergoing Colonoscopy

A Multi-center, Randomized, Two-stage, Phase II Clinical Study Evaluating the Efficacy and Safety of HSK21542 Injection for Analgesia in Subjects Undergoing Diagnostic or Therapeutic Colonoscopy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, two-stage, phase II clinical study .The main objective is to evaluate the safety and tolerability of HSK21542 injection for analgesia in patients undergoing colonoscopy, and, combining the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics

Conditions

• Analgesia

Interventions

Type	Name	Description
DRUG	Stage I: HSK21542 0.5 μg/kg	intravenous injection
DRUG	Stage I: HSK21542 1 μg/kg	intravenous injection
DRUG	HSK21542 0.5 μg/kg	intravenous injection
DRUG	HSK21542 1 μg/kg	intravenous injection
DRUG	HSK21542 2 μg/kg	intravenous injection
DRUG	Placebo	intravenous injection

Timeline

• Start date: 2020-08-19
• Primary completion: 2020-12-28
• Completion: 2021-01-30
• First posted: 2020-07-14
• Last updated: 2023-02-21

Locations

1 site across 1 country: China