NCT07442877

A Phase 2 Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery

A Multi-Center, Randomized, Double-Blind, Placebo/Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Pain Treatment in Orthopedic Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, placebo/active-controlled study. 160 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.

Conditions

• Postoperative Pain Management

Interventions

Type	Name	Description
DRUG	HSK21542 dose level 1	Patients administrated with HSK21542 dose level 1
DRUG	HSK21542 dose level 2	Patients administrated with HSK21542 dose level 2
DRUG	Placebo	Patients administrated with placebo
DRUG	morphine	Patients administrated with morphine

Timeline

• Start date: 2024-09-13
• Primary completion: 2025-01-24
• Completion: 2025-01-24
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: China