A study of intravenous amisulpride as prevention of post-operative nausea and vomiting in children

Phase 3

Completed

• Conditions: post-operative nausea and vomiting in pediatric patients

• Registration Number: 2024-518778-15-00
• Lead Sponsor: Acacia Pharma Limited

Brief Summary

To evaluate the efficacy of IV amisulpride in the prevention of PONV (Prevention of post-operative nausea and vomiting) in pediatric patients.

Detailed Description

Randomized, double-blind, Phase 2/3 study of IV amisulpride as prevention of post-operative nausea and vomiting in pediatric patients

Study Timeline

• Study First Posted: 2025-01-14
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: Ended
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Male or female patients aged from full-term birth (in France, from one month of age) to 17 years of age

Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial

Patients undergoing non-emergency surgery, preferentially eye surgery, adenotonsillectomy or otoplasty, under general anesthesia (other than total intravenous anesthesia with propofol) expected to last at least 30 minutes from induction of anesthesia to removal of ETT or LMA

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

For females of child-bearing potential, defined as fertile, following menarche and until becoming post-menopausal (defined as no menses for 12 months without an alternative medical cause; a high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy, but in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient) unless permanently sterilized by a reliable method such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy: ability and willingness to use a highly effective form of contraception (as defined in the guideline “Recommendations related to contraception and pregnancy testing in clinical trials”, version 1.1, issued by the Clinical Trials Facilitation and Coordination Group of the Heads of Medicines Agency) between the date of screening and at least 48 hours after administration of study drug: • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation: o oral o injectable o implantable • intrauterine device • intrauterine hormone-releasing system • bilateral tubal occlusion • vasectomized partner (provided that partner is the sole sexual partner of the patient and that the vasectomized partner has received medical assessment of the surgical success) • sexual abstinence.

Exclusion Criteria

Patients scheduled to undergo transplant or CNS surgery

Patients being treated with levodopa

Patients who are pregnant or breast feeding

Patients with congenital long QT syndrome, or with factors that predispose to QT prolongation, such as low left ventricular ejection fraction, left ventricular hypertrophy, ischemia, slow heart rate, or electrolyte abnormalities including hypokalemia and hypomagnesemia

Patients with a tumor of the anterior pituitary

Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks

Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study

Patients who have previously participated in this study or who have participated in another interventional clinical study involving pharmacological therapy within the previous 28 days (or longer exclusion period, if required by national or local regulations)

Where local laws/regulations require: patients under legal protection

Patients scheduled to receive only a local anesthetic and/or regional neuraxial (intrathecal or epidural) block (without general anesthesia) or to receive general anesthesia involving total intravenous anesthesia (TIVA) with propofol

Patients who, in the opinion of the Investigator, are expected to remain ventilated for a significant period after surgery

Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed

Patients who are expected to receive systemic pre/peri-operative corticosteroid therapy other than as anti-emetic prophylaxis

Patients receiving amisulpride for any indication within the 2 weeks prior to randomization

Patients known to be allergic to amisulpride or any of the excipients of amisulpride drug product; or to dexamethasone or ondansetron

Patients with a significant ongoing history of vestibular disease or dizziness

Patients being treated with regular anti-emetic therapy (dosed at least three times per week), which is still ongoing less than 1 week prior to screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete Response (absence of PONV), defined as no vomiting/retching and no use of anti-emetic rescue medication, during the first 24 hours after completion of surgery		Complete Response (absence of PONV), defined as no vomiting/retching and no use of anti-emetic rescue medication, during the first 24 hours after completion of surgery

Secondary Outcome Measures

Name	Time	Method
Efficacy: Occurrence of post-operative vomiting/retching		Efficacy: Occurrence of post-operative vomiting/retching
Efficacy: Use of rescue medication		Efficacy: Use of rescue medication
Efficacy: Occurrence and severity of post-operative nausea		Efficacy: Occurrence and severity of post-operative nausea
Efficacy: Time to emergence of PONV		Efficacy: Time to emergence of PONV
Efficacy: Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually		Efficacy: Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually
Efficacy: Different variables (complete response, vomiting/retching, use of rescue medication) during different time ranges after the end of surgery (0-2 h, 2-6 h and 6-24 h)		Efficacy: Different variables (complete response, vomiting/retching, use of rescue medication) during different time ranges after the end of surgery (0-2 h, 2-6 h and 6-24 h)
Efficacy: The above variables in the sub-groups of patients who did and did not receive opioid analgesia		Efficacy: The above variables in the sub-groups of patients who did and did not receive opioid analgesia
Safety: The nature and frequency of adverse events and laboratory and ECG abnormalities		Safety: The nature and frequency of adverse events and laboratory and ECG abnormalities
Key pharmacokinetics parameters		Key pharmacokinetics parameters

Trial Locations

Locations (7)

Universitaetsklinikum Bonn AöR; 🇩🇪 Bonn, Germany

Universitaetsklinikum Wuerzburg AöR; 🇩🇪 Wuerzburg, Germany

HELIOS Klinikum Aue GmbH; 🇩🇪 Aue, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR; 🇩🇪 Mainz, Germany

MVZ Ambulantes Operieren Marburg; 🇩🇪 Marburg, Germany

Les Hopitaux Universitaires De Strasbourg; 🇫🇷 Strasbourg Cedex 2, France

Universitaetsklinikum Giessen und Marburg GmbH; 🇩🇪 Marburg, Germany

Universitaetsklinikum Bonn AöR

🇩🇪Bonn, Germany

Maria Wittmann

Site contact

228287

studienzentrale-szb@ukbonn.de