A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery

NCT07186426 | Recruiting Phase 3

• 1 other identifier: HSK21542-305
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multi-center, randomized, double-blind, placebo/active-controlled study. 405 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.

Conditions

Postoperative Pain Management

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Differences (SPID)

  Sum of Pain Intensity Differences (SPID) of each group

  48 hours

Secondary Outcomes (5)

• Proportion of subjects experiencing nausea

  48 hours

• Proportion of subjects experiencing vomit

  48 hours

• 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

Study Arms (3)

HSK21542

EXPERIMENTAL

Patients administrated with HSK21542

Drug: HSK21542

Placebo control

PLACEBO COMPARATOR

Patients administrated with placebo

Drug: Placebo

Actice control

ACTIVE COMPARATOR

Patients administrated with morphine

Drug: morphine

Interventions

HSK21542 DRUG

Patients administrated with HSK21542

HSK21542

Placebo DRUG

Patients administrated with placebo

Placebo control

morphine DRUG

Patients administrated with morphine

Actice control

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 ⅰ-ⅲ;
• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Jianwei Tang

CONTACT

028-67258779; tangjianw@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 4, 2025
• First Posted: September 22, 2025
• Study Start: July 28, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)