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

Not Applicable

Recruiting

• Conditions: Postoperative Pain Management
• Interventions: Drug: HSK21542; Drug: Placebo; Drug: morphine

• Registration Number: NCT07186426
• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-28
• Status Verified: 2025-09
• Study First Submitted: 2025-09-04
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

• 18 years old ≤ age ≤70 years old, regardless of gender;
• 18 kg/m2≤BMI≤30 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 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HSK21542	HSK21542	Patients administrated with HSK21542
Placebo control	Placebo	Patients administrated with placebo
Actice control	morphine	Patients administrated with morphine

Primary Outcome Measures

Name	Time	Method
Sum of Pain Intensity Differences (SPID)	48 hours	Sum of Pain Intensity Differences (SPID) of each group

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects experiencing nausea	48 hours	Proportion of subjects experiencing nausea of each group
Proportion of subjects experiencing vomit	48 hours	Proportion of subjects experiencing vomit of each group
Sum of Pain Intensity Differences (SPID) in other time frame	0-8 hours, 0-24 hours, 24-48 hours	Sum of Pain Intensity Differences (SPID) in other time frame
Number of times rescue analgesic medications were administered.	48 hours	Number of times rescue analgesic medications were administered.
Total morphine consumption	48 hours	Total morphine consumption of each group

Trial Locations

Locations (2)

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China