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

NCT06170476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-07-09

No results posted yet for this study

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

Interventions

DRUG

HSK21542-60μg

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;

DRUG

HSK21542-120μg

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;

DRUG

HSK21542-180μg

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;

DRUG

Placebo

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;

Sponsors & Collaborators

  • Sichuan Provincial People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2024-02-28
Completion
2024-05-15

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06170476 on ClinicalTrials.gov