Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients

Acacia Pharma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nausea and Vomiting, Postoperative

Treatments: Drug: Dexamethasone; Drug: Amisulpride Injection

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05546359

DP10027

Details and patient eligibility

About

Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting

Full description

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

Enrollment: 453 patients

Sex: All

Ages: 2 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patients aged from full-term birth to 17 years of age
2. Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial
3. 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 Endotracheal tube (ETT) or Laryngeal mask airway (LMA)
4. American Society of Anesthesiologists (ASA) risk score I-III
5. For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (as defined in ICH M3 guidance, e.g., true (not periodic) abstinence from sexual intercourse, surgical sterilization (of subject or partner), combined oral contraceptive pill, or any other method or combination of methods with a failure rate generally considered to be <1% per year) between the date of screening and at least 48 hours after administration of study drug.

Exclusion criteria

1. Patients scheduled to undergo transplant or Central Nervous System (CNS) surgery
2. 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
3. Patients who, in the opinion of the Investigator, are expected to remain ventilated for a significant period after surgery
4. Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
5. Patients who are expected to receive systemic pre/peri-operative corticosteroid therapy other than as anti-emetic prophylaxis
6. Patients receiving amisulpride for any indication within the 2 weeks prior to randomization
7. Patients known to be allergic to amisulpride or any of the excipients of amisulpride drug product; or to dexamethasone or ondansetron
8. Patients with a significant ongoing history of vestibular disease or dizziness
9. 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
10. Patients being treated with levodopa, or any other dopamine D2-agonist
11. Patients who are pregnant or breast feeding
12. Patients with congenital long QT interval (QT) syndrome
13. Patients with a tumor of the anterior pituitary
14. Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks
15. Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
16. 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)
17. Where local laws/regulations require: patients under legal protection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

453 participants in 2 patient groups

Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone

Experimental group

Description:

Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone

Treatment:

Drug: Amisulpride Injection

Drug: Dexamethasone

Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone

Experimental group

Description:

Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone

Treatment:

Drug: Amisulpride Injection

Drug: Dexamethasone