Actively Recruiting
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
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2026-02-13
405
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of HSK21542 injection for managing postoperative pain in patients undergoing orthopedic surgery. This is a Phase III, multi-center, randomized, double-blind, placebo and active-controlled study involving 405 participants. The trial compares HSK21542, morphine, and placebo to understand their effects on pain relief after surgery. Participants will be randomly assigned to receive either HSK21542, morphine, or a placebo. The study treatments are administered following surgery under general anesthesia, specifically for patients undergoing hip replacement. The trial monitors pain intensity and other effects over a 48-hour period post-treatment. During the study, participants will be assessed for pain relief using the Sum of Pain Intensity Differences (SPID) at 48 hours as the primary measure. Secondary measures include nausea and vomiting occurrence, additional pain assessments at shorter intervals, rescue medication use, and total morphine consumption. Safety and effectiveness will be closely monitored throughout the trial lasting until March 2026.
CONDITIONS
Brief Title
A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 74 years, any gender
- Body mass index (BMI) between 18 and 32 kg/m2
- American Society of Anesthesiologists (ASA) grade I to III
- Scheduled for hip replacement surgery under general anesthesia
- Pain score of 4 or higher on the Numeric Rating Scale (NRS) at rest within 4 hours after surgery
- Able to understand and voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Allergy to opioids or any components of the study drugs
- History of severe cardiovascular, cerebrovascular, or psychiatric disorders
- Use of opioid or non-opioid analgesics within 5 half-lives or drugs affecting pain relief within 7 days prior to randomization
- Continuous opioid use for more than 7 days within 30 days before screening
- Abnormal laboratory test results including hematology, prothrombin time, liver or kidney function, or fasting blood glucose
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- History of drug or alcohol abuse
- Participation in any clinical trial within 30 days
- Pregnant or breastfeeding females
- Females of childbearing potential unwilling to use contraception during the study or planning pregnancy within 3 months after the study
- Any other factors deemed by the investigator to make the participant ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 48 hours
Participants receive HSK21542, placebo, or morphine to manage postoperative pain following hip replacement surgery.
1 baseline visit and multiple visits during 48 hours of treatment
Trial Site Locations
Total: 2 locations
1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
Research Team
J
Jianwei Tang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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