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COMPLETED
NCT07442877
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

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

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