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Nausea and Vomiting, PostoperativePhase 4NCT06359535

An Economic Study of HSK21542 Injection for Prevention of Postoperative Nausea and Vomiting

A Phase 4 study testing HSK21542 in people with Nausea and Vomiting, Postoperative, run by Mengchang Yang at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study analyzed the efficacy and safety results of HSK21542 injection for the prevention of postoperative nausea and vomiting in a multicentre, randomized, double-blind, placebo-controlled dose-exploration study, as well as the real-world clinical routine use of troisisone and other (not limited to other setron… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nausea and Vomiting, Postoperative
What is being tested?
HSK21542
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteChina
Study dates
23 Feb 2024to 6 Nov 2024
Phase
Phase 4
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 and ≤75 years old, male or female;
  • The American Society of Anesthesiologists (ASA) Class I-III;
  • 18 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);

Who cannot join

  • 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.
  • 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 test indicators at screening meet the following criteria:White blood cell count < 3.0 × 109/L;Platelet count < 80 × 109/L;Hemoglobin< 70 g/L;Prolongation of prothrombin time (PT) exceeding the upper limit of normal for 3 seconds;Prolongation of activated partial thromboplastin time (APTT) exceeding the upper limit of normal for 10 seconds;Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 × ULN;Total bilirubin > 2 × ULN;Blood creatinine > 2 × ULN;Fasting serum glucose≥ 11.1 mmol/L;
  • Subjects anticipated to require continued endotracheal intubation after the end of surgery;
  • Subjects anticipated to require the insertion of nasal or oral gastric tubes after the end of surgery;
  • Subjects with a history of serious drug allergies or those allergic to the investigational drugs specified in the protocol;
Show all 11Show fewer
  • Subjects with a history of drug abuse, drug addiction, or alcoholism within 3 months prior to screening, where alcoholism is defined as consuming > 2 units of alcohol on average daily (1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol or 150 mL of wine);
  • Subjects with nausea, retching, or vomiting within 24 h prior to induction of anesthesia (except for those caused by bowel preparation);
  • Subjects who have participated in any investigational trial (defined as receiving investigational drug or placebo) within 3 months prior to screening;
  • Female subjects who are pregnant or breastfeeding; female or male subjects of child-bearing potential are unwilling to use contraception throughout the entire study period and for 3 months after the study completion;
  • Subjects judged by the investigator to be unsuitable for participating in this clinical trial for any other factors.

Trial locations and contacts

1 site in 1 country.

Mengchang Yang, Doctor contact

+8618140049936

ymc681@126.com

China1 site, 1 recruiting
  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

    Mengchang Yang, Doctor, +8618140049936, ymc681@126.com

    Mengchang Yang

    Recruiting

Other trials in China

About this study

Official title: An Economic Study on Prevention of Postoperative Nausea and Vomiting by HSK21542 Injection

This study analyzed the efficacy and safety results of HSK21542 injection for the prevention of postoperative nausea and vomiting in a multicentre, randomized, double-blind, placebo-controlled dose-exploration study, as well as the real-world clinical routine use of troisisone and other (not limited to other setron drugs) for the prevention of postoperative nausea and vomiting and related adverse reaction treatment data. It was transformed into an effect indicator, and the possible costs involved in the study were analyzed, reasonable price parameters of HSK21542 injection were set, and the economic value of HSK21542 was explored.

Being tested
HSK21542, Placebo
Medical subject headings
Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSK21542Drug

    This study is an economic study and does not interfere with patients' medical treatment.

  • PlaceboDrug

    Placebo

Study groups in NCT06359535
Study groupRoleWhat they receive
HSK21542-60μgExperimentalHSK21542 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;
Receives: Drug: HSK21542
HSK21542-120μgExperimentalHSK21542 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;
Receives: Drug: HSK21542
HSK21542-180μgExperimentalHSK21542 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;
Receives: Drug: HSK21542
PlaceboPlacebo comparatorA 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;
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total direct medical costs, direct non-medical costs, indirect costs

    Measured: 24 hours after the end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start23 Feb 2024
  3. Primary completion6 Nov 2024 (estimated)
  4. Study completion6 Nov 2024 (estimated)

Resources

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 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06359535
Sponsor's protocol ID
HSK21542-IIT-02
Status last verified
Apr 2024
First submitted
25 Dec 2023
Last updated
11 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Plan to publish articles to share data

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing HSK21542 in people with Nausea and Vomiting, Postoperative, run by Mengchang Yang at 1 site 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mengchang Yang, Doctor (+8618140049936, ymc681@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total direct medical costs, direct non-medical costs, indirect costs (time frame: 24 hours after the end of surgery). 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 11 Apr 2024.

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