Phase II Clinical Study of the Efficacy and Safety of HSK55718 in the Treatment of Abdominal Post… (NCT07491146) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Clinical Study of the Efficacy and Safety of HSK55718 in the Treatment of Abdominal Postoperative Pain
China200 participantsStarted 2026-03-25
Plain-language summary
A multicenter, randomized, double-blind, placebo-controlled, and positive-controlled phase II clinical trial was conducted to evaluate the efficacy and safety of HSK55718 injection for postoperative analgesia in patients undergoing abdominal surgery. The primary objective was to evaluate the efficacy of HSK55718 for postoperative analgesia after abdominal surgery. The secondary objective was to evaluate the safety and pharmacokinetic profile of TRD303 solution for postoperative analgesia after abdominal surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Fully understand, voluntarily participate in this study and sign the informed consent;
✓. Age ≥18 years old, both sexes;
✓. Undergo elective abdominal surgery (open or laparoscopic) with a (estimated) duration of ≥1 hour under general anesthesia;
✓. 18.0 kg/m2≤ body mass index (BMI) ≤30.0 kg/m2
✓. American Society of Anesthesiologists (ASA) grade ⅰ-ⅱ;
✓. NRS≥4 in the resting state at any time within 4 hours after the end of surgery;
✓. Be able to comply with the follow-up schedule and other program requirements;
✓. Participants agreed to use highly effective contraception for the entire duration of the study, from the time they signed the ICF until 3 months after the last dose of the investigational product was administered.
Exclusion criteria
✕. History of vestibular dysfunction or dizziness, nausea, retching or vomiting within 1 week before screening;
✕. Cardiovascular history: severe superior vena cava obstruction syndrome, severe pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, or severe arrhythmia such as atrioventricular block of degree Ⅱ or above, or history of NYHA class II or above;
✕. Respiratory history: history of severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, tracheoesophageal fistula or airway tear, and severe respiratory infection within the last 2 weeks before screening;
What they're measuring
1
The time-weighted summed pain intensity differences over 24 h (SPID0-24 h) at rest
Timeframe: From administration until 24 hours after administration
✕. History of nervous and mental system: history of craniocerebral injury, convulsion, intracranial hypertension, cerebral aneurysm, cerebrovascular accident, ischemic stroke or transient ischemic attack (TIA); History of schizophrenia, mania, psychosis, long-term use of psychotropic drugs, cognitive dysfunction, etc. Depression, anxiety, epilepsy history, etc.
✕. cancer participants with advanced cancer or extensive metastases; 2. Laboratory tests during screening meet any of the following criteria:
✕. Patients with a history of severe drug allergy, or other drugs that may be used during the trial, such as anesthetics propofol/sevoflurane, rocuronium, antiemetic drugs, or drugs and their excipients;
✕. Taking opioid analgesics for any reason for more than 10 consecutive days within 3 months before randomization;
✕. Drugs that may affect the evaluation of efficacy if the time interval between the last administration of the drug and randomization is less than five half-lives of the drug, including but not limited to the following drugs: Selective α2-adrenoceptor agonists, opioid agonists/antagonists, non-steroidal anti-inflammatory drugs, sedative drugs, monoamine oxidase inhibitors, glucocorticoids, antiepileptic, anxiolytic, antidepressant and other antipsychotic drugs. Refer to the list of banned drugs for specific types.