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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Management
• Intervention / Treatment: Drug: Placebo; Drug: morphine; Drug: HSK21542 dose level 1; Drug: HSK21542 dose level 2

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years old ≤ age ≤74 years old, regardless of gender;
• 18 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;

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo control; Patients administrated with placebo	Drug: Placebo; Patients administrated with placebo
Active Comparator: Actice control; Patients administrated with morphine	Drug: morphine; Patients administrated with morphine
Experimental: HSK21542 dose level 1; Patients administrated with HSK21542 dose level 1	Drug: HSK21542 dose level 1; Patients administrated with HSK21542 dose level 1
Experimental: HSK21542 dose level 2; Patients administrated with HSK21542 dose level 2	Drug: HSK21542 dose level 2; Patients administrated with HSK21542 dose level 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum of Pain Intensity Differences (SPID)	Sum of Pain Intensity Differences (SPID) of each group	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum of Pain Intensity Differences (SPID) in other time frame	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.	Number of times rescue analgesic medications were administered.	48 hours
Total morphine consumption	Total morphine consumption of each group	48 hours
Proportion of subjects experiencing nausea and/or vomit	Proportion of subjects experiencing nausea and/or vomit of each group	48 hours

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2024
• Primary Completion (Actual): January 24, 2025
• Study Completion (Actual): January 24, 2025

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Morphine
• Other Study ID Numbers: HSK21542-209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No