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A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
405
Start Date
2025-07-28
Completion Date
2026-03-01
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
HSK21542
Patients administrated with HSK21542
Placebo
Patients administrated with placebo
morphine
Patients administrated with morphine
Locations (2)
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Xiangya Hospital of Central South University
Changsha, Hunan, China