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.
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;
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- 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.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Mengchang Yang, Doctor, +8618140049936, ymc681@126.com
Mengchang Yang
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.
- Conditions
- Nausea and Vomiting, Postoperative
- 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 group | Role | What they receive |
|---|---|---|
| HSK21542-60μg | Experimental | 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; Receives: Drug: HSK21542 |
| HSK21542-120μg | Experimental | 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; Receives: Drug: HSK21542 |
| HSK21542-180μg | Experimental | 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; Receives: Drug: HSK21542 |
| Placebo | Placebo comparator | 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; Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted11 Apr 2024
- Study start23 Feb 2024
- Primary completion6 Nov 2024 (estimated)
- Study completion6 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mengchang Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mengchang Yang, Sichuan Provincial People's Hospital
- Investigators
- Mengchang Yang, Doctor, Principal investigator, Prinipal Investigator
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Economic Study on Prevention of Postoperative Nausea and Vomiting by HSK21542 Injection
- ClinicalTrials.gov ID
- NCT06359535
- Acronym / sponsor ID
- HSK21542-IIT-02
- Conditions
- Nausea and Vomiting, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mengchang YangUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 6 Nov 2024 (estimated)
- Study completion
- 6 Nov 2024 (estimated)
- First posted
- 11 Apr 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSK21542-60μg | Experimental | Drug: HSK21542HSK21542 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; |
| HSK21542-120μg | Experimental | Drug: HSK21542HSK21542 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; |
| HSK21542-180μg | Experimental | Drug: HSK21542HSK21542 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; |
| Placebo | Placebo comparator | Drug: PlaceboA 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; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
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 |
|---|---|---|
| HSK21542This study is an economic study and does not interfere with patients' medical treatment. | Drug | HSK21542-120μg, HSK21542-180μg, HSK21542-60μg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Total direct medical costs, direct non-medical costs, indirect costs
Time frame: 24 hours after the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No. Plan to publish articles to share data
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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.
Mengchang Yang, Doctor principal investigator
Prinipal Investigator
1 site in 1 country: see every site and its status.
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.