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

NCT ID: NCT07186426

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-28
• Study Completion Date: 2026-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HSK21542

Patients administrated with HSK21542

Group Type: EXPERIMENTAL

HSK21542

Intervention Type: DRUG

Patients administrated with HSK21542

Placebo control

Patients administrated with placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients administrated with placebo

Actice control

Patients administrated with morphine

Group Type: ACTIVE_COMPARATOR

morphine

Intervention Type: DRUG

Patients administrated with morphine

Interventions

HSK21542

Patients administrated with HSK21542

Intervention Type: DRUG

Placebo

Patients administrated with placebo

Intervention Type: DRUG

morphine

Patients administrated with morphine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianwei Tang

Role: CONTACT

tangjianw@haisco.com

028-67258779

Facility Contacts

Tianlong Wang

Role: primary

w_tl5595@hotmail.com

139 1052 5304

E Wang

Role: primary

ewang324@csu.edu.cn

18874889950

Other Identifiers

HSK21542-305

Identifier Type: -

Identifier Source: org_study_id