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A Phase 2 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. 160 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 II 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
161
Start Date
2024-09-13
Completion Date
2025-01-24
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
HSK21542 dose level 1
Patients administrated with HSK21542 dose level 1
HSK21542 dose level 2
Patients administrated with HSK21542 dose level 2
Placebo
Patients administrated with placebo
morphine
Patients administrated with morphine
Locations (27)
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China
The Third Affiliated Hospital, Southern Medical University
Guangzhou, Guangdong, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine
Cangzhou, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Yichang Central People's Hospital (Wujia Campus)
Yichang, Hubei, China
Yichang Central People's Hospital (Xiling Campus)
Yichang, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Huai'an Second People's Hospital
Huaian, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Mianyang Orthopedic Hospital
Mianyang, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Jinhua Central Hospital
Jinhua, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Huashan Hospital, Fudan University
Shanghai, China
Shenzhen Second People's Hospital
Shenzhen, China