Preventing of Postoperative Nausea and Vomiting in AdultsPhase 2NCT06475846
A Trial of HRS5580 in Prevention of Postoperative Nausea and Vomiting of Adults
A Phase 2 study testing HRS5580, Ondansetron and blank preparation in people with Preventing of Postoperative Nausea and Vomiting in Adults, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preventing of Postoperative Nausea and Vomiting in Adults
- What is being tested?
- HRS5580, Ondansetron and blank preparation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 2 sitesChina
- Study dates
- 25 Jun 2024to 29 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Third Xiangya Hospital of Central South University
Changsha, Hu'nan, 410013
About this study
Official 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
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.
- Being tested
- HRS5580, Ondansetron, blank preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS5580Drug
HRS5580; low dose
HRS5580Drug
HRS5580; middle dose
HRS5580Drug
HRS5580; middle dose
OndansetronDrug
Ondansetron
blank preparationDrug
blank preparation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS5580 | Experimental | Not described Receives: Drug: HRS5580 |
| Treatment group B: HRS5580 | Experimental | Not described Receives: Drug: HRS5580 |
| Treatment group C: HRS5580 | Experimental | Not described Receives: Drug: HRS5580 |
| Treatment group D: Ondansetron | Active comparator | Not described Receives: Drug: Ondansetron |
| Treatment group E: blank preparation. | Placebo comparator | Not described Receives: Drug: blank preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
No vomiting rate within 72 hours after extubation
Measured: 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
Measured: at24, 48, 72, 96, and 120 hours after extubation
No vomiting at 24, 48, 96, and 120 hours after extubation,
Measured: 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
Measured: 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
Measured: at 24, 48, 72, 96, and 120 hours of extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start25 Jun 2024
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventing of Postoperative Nausea and Vomiting in AdultsStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475846
- Sponsor's protocol ID
- HRS5580-201
- Status last verified
- Jan 2025
- First submitted
- 13 Jun 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06475846
- Acronym / sponsor ID
- HRS5580-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS5580HRS5580; low dose | Drug | Treatment group A: HRS5580 |
| HRS5580HRS5580; middle dose | Drug | Treatment group B: HRS5580 |
| HRS5580HRS5580; middle dose | Drug | Treatment group C: HRS5580 |
| OndansetronOndansetron | Drug | Treatment group D: Ondansetron |
| blank preparationblank preparation. | Drug | Treatment group E: blank preparation. |
Primary outcome
No vomiting rate within 72 hours after extubation
Time frame: at 72 hours after extubation
4 secondary outcomes
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
No vomiting at 24, 48, 96, and 120 hours after extubation,
Time frame: 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
Time frame: 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
Time frame: at 24, 48, 72, 96, and 120 hours of extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS5580, Ondansetron and blank preparation in people with Preventing of Postoperative Nausea and Vomiting in Adults, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No vomiting rate within 72 hours after extubation (time frame: at 72 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.