Status:
RECRUITING
A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Postoperative Pain Management
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT07186426
Start Date
July 28 2025
End Date
March 1 2026
Last Update
September 22 2025
Active Locations (2)
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1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
2
Xiangya Hospital of Central South University
Changsha, Hunan, China