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

NCT06475846 | Completed Phase 2

• 1 other identifier: HRS5580-201
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Preventing of Postoperative Nausea and Vomiting in Adults

Outcome Measures

Primary Outcomes (1)

• No vomiting rate within 72 hours after extubation

  at 72 hours after extubation

Secondary Outcomes (4)

• 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

  at24, 48, 72, 96, and 120 hours after extubation

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

  at 24, 48, 96, and 120 hours after extubation

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

  at 24, 48, 72, 96, and 120 hours after extubation

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

  at 24, 48, 72, 96, and 120 hours of extubation

Study Arms (5)

Treatment group A: HRS5580

EXPERIMENTAL

Drug: HRS5580

Treatment group B: HRS5580

EXPERIMENTAL

Drug: HRS5580

Treatment group C: HRS5580

EXPERIMENTAL

Drug: HRS5580

Treatment group D: Ondansetron

ACTIVE COMPARATOR

Drug: Ondansetron

Treatment group E: blank preparation.

PLACEBO COMPARATOR

Drug: blank preparation

Interventions

HRS5580 DRUG

HRS5580; low dose

Treatment group A: HRS5580

Ondansetron DRUG

Ondansetron

Treatment group D: Ondansetron

blank preparation DRUG

blank preparation.

Treatment group E: blank preparation.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Third Xiangya Hospital of Central South University

Changsha, Hu'nan, 410013, China

Location

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 26, 2024
• Study Start: June 25, 2024
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

CN (2)