RecruitingPhase 3NCT07186426

A 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 III Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Pain Treatment in Orthopedic Surgery

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Enrollment

405 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain Management

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.

Eligibility

Min Age: 18 YearsMax Age: 74 Years

Inclusion Criteria6

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;

Exclusion Criteria11

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.