NCT07186426

A 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 III Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Pain Treatment in Orthopedic Surgery

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 405 (estimated)
• 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. 405 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	Patients administrated with HSK21542
DRUG	Placebo	Patients administrated with placebo
DRUG	morphine	Patients administrated with morphine

Timeline

• Start date: 2025-07-28
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-09-22
• Last updated: 2026-02-13

Locations

2 sites across 1 country: China