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Completed

NCT Number: NCT06475846

A Trial of HRS5580 in Prevention of Postoperative Nausea and Vomiting of Adults

The study is being conducted to evaluate the efficacy, and safety of HRS5580 for preventing of postoperative nausea and vomiting in adults. To explore the reasonable dosage of HRS5580 for postoperative nausea and vomiting.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to provide a written informed consent
  • Plan to undergo elective surgery under general anesthesia;
  • ≥18 years old
  • Meet the weight standard
  • Conform to the ASA Physical Status Classification
  • Expected postoperative hospital stay ≥72 hours
  • PONV risk factors ≥3

Exclusion criteria

  • Subjects with vomiting and/or retching and nausea occurred before surgery
  • Subjects with a history of vestibular disease, central nervous system and other system diseases
  • Subjects with a previous history of chronic nausea or vomiting/retching
  • Subjects with a history of myocardial infarction or unstable angina pectoris
  • Subjects with atrioventricular block or cardiac insufficiency
  • Subjects with a history of ischemic stroke or transient ischemic attack
  • Subjects with poor blood pressure control after medication
  • Abnormal electrocardiogram
  • Abnormal values in the laboratory
  • Allergic to a drug ingredient or component
  • Received treatment with potential antiemetic effects before starting the investigational product
  • Subjects who received chemotherapy prior to surgery
  • Use of drugs that affect the antiemetic effect, and the time between the last use of the test drug and the start of the time is less than 5 half-lives
  • Plan to receive local anesthesia only or total intravenous anesthesia only
  • Subjects who are expected to require an in-situ nasogastric tube or orogastric tube after completion of surgery
  • Subjects expected to be transferred to the ICU at the end of surgery
  • Pregnant or nursing women
  • No birth control during the specified period of time
  • Participated in clinical trials of other drugs (received experimental drugs)
  • The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Treatment and study plan

HRS5580

Drug

HRS5580; low dose

ondansetron

Drug

Ondansetron

blank preparation

Drug

blank preparation.

Primary outcomes

  1. No vomiting rate within 72 hours after extubation

    Time frame: at 72 hours after extubation

Secondary outcomes

  1. Complete response rate (defined as the proportion of subjects without vomiting and receiving no rescue therapy) at 24, 48, 72, 96, and 120 hours after extubation

    Time frame: at24, 48, 72, 96, and 120 hours after extubation

  2. No vomiting at 24, 48, 96, and 120 hours after extubation,

    Time frame: at 24, 48, 96, and 120 hours after extubation

  3. Proportion of subjects who did not experience significant nausea within 24, 48, 72, 96, and 120 hours after extubation

    Time frame: at 24, 48, 72, 96, and 120 hours after extubation

  4. Proportion of participants not receiving rescue medication within 24, 48, 72, 96, and 120 hours of extubation

    Time frame: at 24, 48, 72, 96, and 120 hours of extubation

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Evaluate HRS5580 for Injection for Prevention of Postoperative Nausea and Vomiting Efficacy and Safety of Ⅱ Period, Randomized, Multicenter, Dose of Exploration, Positive Control, Placebo-controlled, Double-blind, Double Simulation Trials

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.