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

NCT05390905 | Completed Phase 3

• 1 other identifier: HSK21542-303
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, randomized, double-blind, placebo/active-controlled study. About 387 subjects undergoing elective abdominal operation under general anesthesia are planned to be enrolled and randomized into the HSK21542 group (129 subjects), tramadol group (129 subjects), and placebo group (129 subjects).

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (3)

• Sum of Pain Intensity Differences (SPID) in the HSK21542 group and the placebo group

  Time-weighted SPID at rest within 0-24 h after the first administration in the HSK21542 group and the placebo group

  From administration until 24 hours after administration

• Sum of Pain Intensity Differences (SPID) in tramadol group and the placebo group

  Time-weighted SPID at rest within 0-24 h after the first administration in the tramadol group and the placebo group

  From administration until 24 hours after administration

• Sum of Pain Intensity Differences (SPID) in the HSK21542 group and the tramadol group

  Time-weighted SPID at rest within 0-24 h after the first administration in the HSK21542 group and the tramadol group

  From administration until 24 hours after administration

Secondary Outcomes (9)

• Use of remedial analgesics within 0-12 h

  From administration until 12 hours after administration

• Use of remedial analgesics within 0-24 h

  From administration until 24 hours after administration

• Sum of Pain Intensity Differences (SPID) in each group

  From administration until 12 hours after administration

• Pain intensity difference (PID)

  From administration until 24 hours after administration

• Numerical rating scale（NRS）in each group

  From administration until 24 hours after administration

Study Arms (3)

HSK21542

EXPERIMENTAL

HSK21542 injection

Drug: HSK21542 Injection

tramadol

EXPERIMENTAL

Tramadol hydrochloride injection

Drug: Tramadol hydrochloride

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

HSK21542 Injection DRUG

1μg/kg/dose

Also known as: HSK21542

HSK21542

Tramadol hydrochloride DRUG

50mg/dose

Also known as: Tramadol

tramadol

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, male or female;
• The American Society of Anesthesiologists (ASA) Class I-II;
• kg/m2 ≤ BMI (body mass index) ≤ 40 kg/m2;
• Subjects undergoing elective abdominal operation under general anesthesia (including laparoscopic surgery);
• Subjects with an NRS score ≥ 4 at rest within 4 h after the surgery (when the last stitch of suture is completed) determined by investigators;
• Subjects who agree to participate in this trial and voluntarily sign the informed consent form.

You may not qualify if:

• Previous and concomitant diseases
• \. Subjects with a history or evidence of any of the following diseases before 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, serious arrhythmia, heart failure, Adams-stokes syndrome, the New York Heart Association (NYHA) Class ≥ III, serious superior vena cava syndrome, serious 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 subjects with pacemakers);
• History of respiratory system disorders: serious chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, serious airway stenosis, throat mass, history of tracheoesophageal fistula or airway tear, serious respiratory infection within 2 weeks before screening;
• History of neurologic 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.;
• History of acute poisoning with alcohol, hypnotics, analgesics, or other central nervous system acting drugs;
• History of any major surgery within 3 months before screening, which may affect postoperative pain assessment as judged by investigators.
• Past and concomitant medications 2. Known allergies or contraindications to opiates and other drugs that might be used in the clinical trial such as anesthetics (propofol/sevoflurane), muscle relaxants (cisatracurium), antiemetics (tropisetron); 3. Receipt of any one of the following medications or treatments at screening(with the exception of drugs specified in the protocol):
• 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 with the interval between the last administration and randomization shorter than 5 half-lives of the drug or the duration of response (whichever is longer);
• Consecutive use of opioid analgesics for any reason of more than 10 days within 3 months before screening;
• Use of drugs with unknown half-lives that affect the analgesic effects within 14 days before randomization, or use of drugs that affect the analgesic effects with the interval between the last administration and randomization within 5 half-lives or duration of drug effect (calculated at maximum) (as per the packaging insert); such drugs include but are not limited to: sedative hypnotics (benzodiazepines \[triazolam, diazepam, midazolam, etc.\], non-benzodiazepines \[zolpidem, zopiclone, zaleplon, etc.\]), sedative anesthetics (anesthetic ether, nitrous oxide, sodium thiopental, 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 that may affect efficacy evaluation as judged by investigators;
• Use of diuretics and compound drugs containing diuretics with the interval between the last administration and randomization shorter than 5 half-lives of the drug or the duration of response (whichever is longer).
• Laboratory and other tests 4. The laboratory test parameters measured at screening reach one of the following criteria:
• White blood cell count \< 3.0 x 109/L;
• Platelet count \< 80 x 109/L;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong U

Wuhan, 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

MeSH Terms

Interventions

Tramadol

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

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: May 12, 2022
• First Posted: May 25, 2022
• Study Start: June 8, 2022
• Primary Completion: December 16, 2022
• Study Completion: March 28, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

CN (1)