A Clinical Study to Evaluate Efficacy and Safety of HSK21542 for Postoperative Analgesia of Subjects Undergoing Elective Laparoscopic Surgery Under General Anesthesia

NCT04738357 | Completed Phase 3

• 1 other identifier: HSK21542-301
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-center, randomized, double-blind, placebo-controlled study. A total of 276 subjects undergoing elective laparoscopic surgery under general anesthesia are planned to be enrolled and randomized into 2 groups, i.e., the HSK21542 group (138 subjects) and the placebo group (138 subjects).

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Differences (SPID)

  The time-weighted SPID at rest within 0-24 h after the first postoperative administration in each group

  Frome administration until 24 hours after administration

Secondary Outcomes (8)

• Sum of Pain Intensity Differences (SPID)

  Frome administration until 12 hours after administration

• Use of remedial analgesics

  Frome administration until 24 hours after administration

• Pain Intensity Differences（PID）

  Frome administration until 24 hours after administration

• The proportion of subjects with a NRS of ≤ 3

  Frome administration until 24 hours after administration

• Duration of analgesia

  Frome administration until 24 hours after administration

Study Arms (2)

HSK21542

EXPERIMENTAL

Drug: HSK21542

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HSK21542 DRUG

HSK21542：1 µg/kg

HSK21542

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ age ≤ 70 years old, with no gender requirement;
• American Society of Anesthesiologists (ASA) Class I-II;
• BMI ≥ 18 kg/m2 and ≤ 40 kg/m2;
• Subjects undergoing elective laparoscopic surgery under general anesthesia with an expected surgery duration of 1-5 h (inclusive);
• Agree to participate in this trial and voluntarily sign the informed consent form;

You may not qualify if:

• With a history of allergy to opioids, such as urticaria, or allergic to intraoperative anesthetics as prescribed in the protocol;
• Patients with history or evidence of any of the following diseases prior to screening:
• History of cardiovascular diseases: uncontrolled hypertension (systolic blood pressure \[SBP\] ≥ 170 mmHg and/or diastolic blood pressure \[DBP\] ≥ 105 mmHg without treatment, or SBP \> 160 mmHg and/or DBP \> 100 mmHg despite antihypertensive treatment), aneurysm, severe arrhythmia, heart failure, Adams-stokes syndrome, New York Heart Association (NYHA) Class ≥ III, severe superior vena cava syndrome, pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medical treatment, II-III degree atrioventricular block (excluding patients with pacemakers);
• History of respiratory system disorders: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, history of tracheoesophageal fistula or airway tear, severe respiratory infection within 2 weeks prior to screening;
• History of neurological and psychiatric disorders: craniocerebral injury, convulsions, intracranial hypertension, cerebral aneurysms, history of cerebrovascular accidents; schizophrenia, mania, insanity, long-term use of psychotropic drugs, and history of cognitive dysfunction; history of depression, anxiety, and epilepsy, etc.;
• Have undergone any major surgery within 3 months prior to screening, which may affect postoperative pain assessment as judged by the investigator;
• In receipt of any one of the following medications or treatments at screening:
• A time between the last use of opioid and non-opioid (such as paracetamol, aspirin \[daily dose \> 100 mg\], indometacin, diclofenac, parecoxib sodium, and other non-steroidal anti-inflammatory drugs) analgesics and randomization of shorter than 5 half-lives of the drug or the duration of response (whichever is longer);
• Longer than 10 days of continuous use of opioid analgesics for any reason within 3 months prior to screening;
• Use of drugs with unknown half-life that affect the analgesic effect within 14 days before randomization, or the last use of drugs that affect the analgesic effect is within 5 half-lives (as per the packaging insert of the drug) apart from randomization, such drugs include but are not limited to: sedative-hypnotics (benzodiazepines \[triazolam, diazepam, midazolam, etc.\], non-benzodiazepines \[zolpidem, zopiclone, zaleplon, etc.\]), sedative anesthetics (sevoflurane, anesthetic ether, nitrous oxide, thiopental sodium, ketamine, etomidate, etc.), glucocorticoids (dexamethasone hydrochloride, methylprednisolone, etc.), antiepileptics (carbamazepine, sodium valproate, etc.), anxiolytics (chlordiazepoxide, diazepam, etc.), antidepressants (imipramine, amitriptyline, etc.), and Chinese herbal medicines or Chinese patent medicines with analgesic and sedative effects;
• Expected to receive any anti-tumor drug or therapy from 14 days prior to randomization to the end of the follow-up period, including but not limited to chemotherapy drugs, targeted drugs, and Chinese herbal medicines;
• A time between randomization and the last use of diuretics and compound drugs containing diuretics of shorter than 5 half-lives of the drug or the duration of response (whichever is longer);
• The laboratory parameters measured at screening period reach one of the following criteria:
• WBC \< 3.0 × 109/L;
• Platelet count \< 80 × 109/L;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

Related Publications (1)

• Zhong Y, Xu Y, Lei Q, Yang M, Wang S, Hu X, Xie H, Li Y, Qin Z, Gu Z, Zhang J, Wang Y, Wu J, Wang H, Ming Y, Xia Z, Zhai H, Jiang K, Zhang P, Wang Z, Wang L, Li L, Cheng Z, Jiang H, Wang G, Chen J, Zhao Z, Chen X, Yan M. HSK21542 in patients with postoperative pain: two phase 3, multicentre, double-blind, randomized, controlled trials. Nat Commun. 2025 May 24;16(1):4830. doi: 10.1038/s41467-025-60013-y.

  PMID: 40413233 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 4, 2021
• Study Start: March 24, 2021
• Primary Completion: July 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 21, 2023

Record last verified: 2022-05

Locations

CN (1)