A Randomized, Double-blind, Placebo-controlled, Two-stage Phase II Study Evaluating the Efficacy and Safety of HSK21542 in Inducing Postoperative Analgesia in Subjects Undergoing Elective Laparoscopic Surgery Under General Anesthesia

Haisco Pharmaceutical Group Co., Ltd.1 site in 1 country124 target enrollmentJuly 2, 2020

ConditionsAnalgesia

InterventionsPlacebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Analgesia
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Enrollment: 124
Locations: 1
Primary Endpoint: Sum of Pain Intensity Differences (SPID)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, two-stage phase II clinical study. The main objective is to evaluate the efficacy and safety of HSK21542 injection and explore the recommended dose and administration frequency for subsequent Phase II studies in conjunction with the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics.

Registry

clinicaltrials.gov

Start Date

July 2, 2020

End Date

January 5, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 ≤ age ≤ 70 years old, with no gender requirement
•American Society of Anesthesiologists (ASA) Class I-II
•18 kg/m\^2 ≤ BMI ≤ 40 kg/m\^2
•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;

Exclusion Criteria

•History of allergy to opioids, such as urticaria, or allergic to the intraoperative anesthetics prescribed in the protocol;
•History or evidence of any one 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 without antihypertensive 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 caval syndrome, pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction in the last 6 months before screening, history of tachycardia/bradycardia requiring medication, and II-III degree atrioventricular block (excluding patients with pacemakers);
•History of respiratory disorder: Severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe bronchostenosis, throat mass, history of (bronchial) tracheoesophageal fistula or airway tear, and severe respiratory tract infection in the last 2 weeks before screening;
•History of disorders in the nervous and psychiatric system: History of craniocerebral injury, possible convulsions, intracranial hypertension, cerebral aneurysms, and history of cerebrovascular accidents; history of schizophrenia, mania, mental aberration, long-term use of psychotropic drugs, and cognitive disorder; history of depression, anxiety, and epilepsy, etc.;
•Underwent major surgery within 3 months before screening and was judged by the investigator to have potential effect on the postoperative pain evaluation;
•Any of the following airway management risks during screening:
•Acute asthma attacks;
•Sleep apnea syndrome;
•History or family history of malignant hyperthermia;

Arms & Interventions

Postoperative: Placebo

Placebo；intravenous injection

Intervention: Placebo

Outcomes

Primary Outcomes

Sum of Pain Intensity Differences (SPID)

Time Frame: Frome administration until 24 hours after administration

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

Secondary Outcomes

The proportion of subjects with a NRS of ≤ 3(Frome administration until 24 hours after administration)
Sum of Pain Intensity Differences (SPID)(Frome administration until 24 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)
Duration of analgesia(Frome administration until 24 hours after administration)
Satisfaction scores on postoperative analgesia(Frome administration until 24 hours after administration)