A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in PONV

NCT06170476 | Completed

• 1 other identifier: HSK21542-IIT-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled Dose-Finding study. About 200 subjects undergoing elective laparoscopic abdominal or gynecological surgery are planned to be enrolled and randomized into four groups by a ratio of 1:1:1:1.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Complete response

  The primary efficacy analysis was the complete response (CR)within the 24 hours after the end of surgery (CR was defined as no vomiting or retching and on use of rescue medication)

  24 hours after the end of surgery

Secondary Outcomes (7)

• Proportion of subjects experiencing nausea within 24 hours after the end of surgery

  24 hours after the end of surgery

• Proportion of subjects experiencing significant nausea within 24 hours after the end of surgery

  24 hours after the end of surgery

• Proportion of subjects experiencing vomiting within 24 hours after the end of surgery

  24 hours after the end of surgery

• Proportion of subjects using rescue medication within 24 hours after the end of surgery

  24 hours after the end of surgery

• Time to first occurrence of vomiting or rescue therapy (whichever occurs first) within 24 hours after the end of surger

  24 hours after the end of surgery

Study Arms (4)

HSK21542-60μg

EXPERIMENTAL

Drug: HSK21542-60μg

HSK21542-120μg

EXPERIMENTAL

Drug: HSK21542-120μg

HSK21542-180μg

EXPERIMENTAL

Drug: HSK21542-180μg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HSK21542-60μg DRUG

HSK21542 injection of 60 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;

HSK21542-60μg

HSK21542-120μg DRUG

HSK21542 injection of 120 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;

HSK21542-120μg

HSK21542-180μg DRUG

HSK21542 injection of 180 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;

HSK21542-180μg

Placebo DRUG

A placebo was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤75 years old, male or female;
• The American Society of Anesthesiologists (ASA) Class I-III;
• kg/m2 ≤ BMI ≤ 40 kg/m2;
• Hospitalized subjects scheduled to undergo elective laparoscopic abdominal or gynecological surgery under general anesthesia for an expected anesthetic time of ≥ 1 h;
• Subjects with intermediate or high risk (score ≥ 2 points) experiencing PONV judged by the investigator using the Apfel simplified risk score;
• Subjects who agree to participate in the trial and voluntarily sign the Informed Consent Form (ICF);

You may not qualify if:

• Prior and concomitant diseases
• History or evidence of any of the following diseases prior to screening:
• Respiratory diseases: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, large pharyngolaryngeal mass, (broncho) tracheoesophageal fistula or airway tear, and serious respiratory tract infection within 2 weeks prior to screening;
• Central nervous system disorders: subjects with epilepsy, Parkinson's disease, or other central nervous system diseases causing nausea and vomiting, such as craniocerebral injury, intracranial space-occupying lesions, intracranial aneurysms, etc.;
• Cardiovascular diseases: subjects with uncontrolled hypertension \[systolic blood pressure (SBP) ≥170 mmHg and/or diastolic blood pressure (DBP) ≥105 mmHg without treatment with antihypertensive medication, or SBP ≥160 mmHg and/or DBP ≥100 mmHg after treatment with antihypertensive medications\], serious cardiac insufficiency ( the New York Heart Association \[NYHA\] Grade III-IV), unstable angina pectoris, acute myocardial infarction, severe arrhythmia, history of tachycardia/bradycardia requiring medical treatment, Grade II-III atrioventricular block (excluding pacemaker use) within 6 months prior to screenin;
• Digestive disorders: subjects with intestinal obstruction or other digestive diseases that may cause nausea and vomiting as judged by the investigator;
• Patients with a confirmed diagnosis of vestibular function disorder, excluding travel sickness (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.);
• Subjects with a history of significant and chronic dizziness.
• Prior and concomitant medications
• Any of the following medications or treatments have been used at screening:
• Subjects who have received antiemetics/medications with antiemetic effects within 24 h before the start of surgery or who have used antiemetics/drugs with antiemetic effects before the start of surgery for no more than 5 half-lives (calculated as the longest time);
• Subjects with neoplasm malignant treated with chemotherapy within 4 weeks prior to screening;
• Laboratory and other tests
• Laboratory test indicators at screening meet the following criteria:
• White blood cell count \< 3.0 × 109/L;

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Sichuan, China

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: November 10, 2023
• Primary Completion: February 28, 2024
• Study Completion: May 15, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CN (1)