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

Haisco Pharmaceutical Group

Status and phase: Enrolling; Phase 3

Conditions: Postoperative Pain Management

Treatments: Drug: HSK21542; Drug: Placebo; Drug: morphine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07186426

HSK21542-305

Details and patient eligibility

About

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.

Enrollment: 405 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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405 participants in 3 patient groups, including a placebo group

HSK21542

Experimental group

Description:

Patients administrated with HSK21542

Treatment:

Drug: HSK21542

Placebo control

Placebo Comparator group

Description:

Patients administrated with placebo

Treatment:

Drug: Placebo

Actice control

Active Comparator group

Description:

Patients administrated with morphine

Treatment:

Drug: morphine