A Comparison of the Efficacy of Amisulpride and Placebo in the Prevention of PONV in Patients at Moderate-to-high Risk of PONV.

April 9, 2023 updated by: Qilu Pharmaceutical (Hainan) Co., Ltd.

Randomized, Double-blind, Placebo-controlled Phase III Study of Amisulpride for IV Injection as Prophylaxis Against Post-operative Nausea and Vomiting

A comparison of the efficacy of Amisulpride and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
516

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Inclusion Criteria:

  1. Participant understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.
  2. Male or female patients ≥ 18 years of age and ≤75 years of age.
  3. 18<BMI≤30kg/m^2，And weigh more than 45kg
  4. Patients undergoing elective surgery(laparoscopic gynecological or abdominal surgery) under general anaesthesia requiring，and inhalation anesthesia is maintained for more than 1 hour, but patients who receive purely diagnostic surgery cannot be enrolled;

  5. Patients with at least 2 of the following risk factors for PONV:

    Past history of PONV and/or motion sickness Habitual non-smoking status Female sex Expected to receive opioid analgesia post-operatively

  6. American Society of Anesthesiologists (ASA) risk score I-III -

Exclusion Criteria:

  1. Patients undergoing day case surgery
  2. Patients undergoing intra-thoracic, transplant or central nervous system surgery or any surgery where post-operative emesis may pose a significant danger to the patient
  3. Patients planned to receive only a local anaesthetic and/or regional neuraxial (intrathecal or epidural) block
  4. Patients who are scheduled to be transferred to the ICU after surgery;
  5. Patients who are expected to need a naso- or oral-gastric tube in situ after surgery is completed
  6. Patients who have a documented, clinically significant cardiac arrhythmia or congenital long QT syndrome（Male≥ 450 ms female≥ 460ms）.
  7. Adequate hepatic and renal function, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2.5 x upper limit normal (ULN)，Bilirubin ≥ 1.5 x ULN，Creatinine ≥ 1.5x ULN
  8. Patients who have received Amisulpride active ingredient for any indication within the last 2 weeks
  9. Patients who are allergic to Amisulpride active ingredient or any of the excipients of Amisulpride
  10. Patients with a significant, ongoing history of vestibular disease or dizziness
  11. Intestinal obstruction
  12. Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or breast cancer) or phaeochromocytoma.
  13. Patients with pre-existing nausea or vomiting in the 24 hours before surgery
  14. Patients treated with regular anti-emetic therapy including corticosteroids
  15. Patients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin
  16. Patients being treated with levodopa or other dopamine drugs
  17. Patients who are pregnant or breast feeding.
  18. Participant who has a history of drug or alcohol abuse within 6 months before randomization
  19. Patients diagnosed with Parkinson's disease ，Patients with a history of epilepsy.
  20. Patients who have received anti-cancer chemotherapy in the previous 4 weeks of surgery
  21. Patients who have participated in other clinical research trials within 3 months before randomization
  22. Participant who may increase study-related risks or interfere with the interpretation of study results in the opinion of the investigator, who are considered unsuitable for enrollment by the investigator and/or the sponsor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Amisulpride at 5mg was given by slow iv administration during1 to 2 min at induction of anesthesia
Drug: Amisulpride
5mg/2ml
Placebo Comparator: Placebo
Placebo was given by slow iv administration during1 to 2 min at induction of anesthesia
Drug: Amisulpride Placebo
2ml

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary endpoint was the composite measure complete response
Time Frame: 24 hours after the end of surgery
defined as no episodes of emesis (vomiting or retching) and no use of rescue medication in the first 24h after wound closure
24 hours after the end of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to First Violation of Criteria for PONV
Time Frame: 24 hours after end of surgery
Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery
24 hours after end of surgery
Use of Rescue Medication
Time Frame: 24 hours after end of surgery
24 hours after end of surgery
Incidence of no Nausea
Time Frame: 24 hours after end of surgery
Count of patients experiencing an episode of no nausea scored < 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery
24 hours after end of surgery
Incidence of moderate and severe Nausea
Time Frame: 24 hours after end of surgery
Count of participants with nausea score > 4 on 0-10 verbal response scale
24 hours after end of surgery
Incidence of Emesis (Vomiting/Retching)
Time Frame: 24 hours after end of surgery
An assessment of a participant experiencing an episode of emesis (vomiting/ retching) during the 24hours after the completion of the surgery
24 hours after end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Pharmaceutical (Hainan) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: yi feng, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QLG2069-AMS-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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