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
1 other identifier
interventional
161
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2024
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2025
CompletedFirst Submitted
Initial submission to the registry
February 11, 2026
CompletedFirst Posted
Study publicly available on registry
March 2, 2026
CompletedSeptember 29, 2026
February 1, 2026
4 months
February 11, 2026
September 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Sum of Pain Intensity Differences (SPID)
Sum of Pain Intensity Differences (SPID) of each group
48 hours
Secondary Outcomes (4)
Sum of Pain Intensity Differences (SPID) in other time frame
0-8 hours, 0-24 hours, 24-48 hours
Number of times rescue analgesic medications were administered.
48 hours
Total morphine consumption
48 hours
Proportion of subjects experiencing nausea and/or vomit
48 hours
Study Arms (4)
HSK21542 dose level 1
EXPERIMENTALPatients administrated with HSK21542 dose level 1
HSK21542 dose level 2
EXPERIMENTALPatients administrated with HSK21542 dose level 2
Placebo control
PLACEBO COMPARATORPatients administrated with placebo
Actice control
ACTIVE COMPARATORPatients administrated with morphine
Interventions
Eligibility Criteria
You may qualify if:
- years old ≤ age ≤74 years old, regardless of gender;
- kg/m2≤BMI≤32 kg/m2, meet the weight range specified in the protocol;
- American Society of Anesthesiologists (ASA) grade 1-3;
- Accept hip replacement under general anesthesia;
- Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
- Fully understand and voluntarily participate this trial, and sign the informed consent form;
You may not qualify if:
- Patients with allergy to opioids or any component of the trial drug;
- Patients with a history of severe cardiovascular and cerebrovascular diseases, ,and psychiatric disorders;
- Last use of opioid or non-opioid analgesics less than 5 half-lives or the duration of drug efficacy prior to randomization; use of drugs with unclear half-lives that may affect analgesic efficacy within 7 days prior to randomization, or last use of drugs affecting analgesic efficacy less than 5 half-lives prior to randomization, as well as Chinese herbal medicines or proprietary Chinese medicines deemed by the investigator as potentially impacting the evaluation of efficacy and safety;
- Continuous use of opioid analgesics for more than 7 days for any reason within 30 days prior to screening;
- Laboratory test results during the screening period meeting any of the following criteria: 1) Significantly abnormal hematology results; 2) Significantly abnormal prothrombin time test results; 3) Significantly abnormal liver or kidney function; 4) Significantly abnormal fasting blood glucose;
- Positive test results during the screening period for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody;
- A history of drug, drug, and/or alcohol abuse
- Participate in any clinical trail within 30 days;
- Pregnant or lactating female subjects;
- Subjects of childbearing potential who are unwilling to use contraception throughout the study period or plan to become pregnant within 3 months after the study.
- Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2026
First Posted
March 2, 2026
Study Start
September 13, 2024
Primary Completion
January 24, 2025
Study Completion
January 24, 2025
Last Updated
September 29, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share