COMPLETED

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

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Conditions

Nausea and Vomiting, Postoperative

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Randomized, Double-blind, Phase 2/3 Study of IV Amisulpride as Prevention of Post-operative Nausea and Vomiting in Pediatric Patients

Quick Facts

Study Start:2024-01-18
Study Completion:2025-06-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05546359

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.

Ages Eligible for Study:2 Months to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female patients aged from full-term birth to 17 years of age
  2. 2. Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial
  3. 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. 4. American Society of Anesthesiologists (ASA) risk score I-III
  5. 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.
  1. 1. Patients scheduled to undergo transplant or Central Nervous System (CNS) surgery
  2. 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. 3. Patients who, in the opinion of the Investigator, are expected to remain ventilated for a significant period after surgery
  4. 4. Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
  5. 5. Patients who are expected to receive systemic pre/peri-operative corticosteroid therapy other than as anti-emetic prophylaxis
  6. 6. Patients receiving amisulpride for any indication within the 2 weeks prior to randomization
  7. 7. Patients known to be allergic to amisulpride or any of the excipients of amisulpride drug product; or to dexamethasone or ondansetron
  8. 8. Patients with a significant ongoing history of vestibular disease or dizziness
  9. 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. 10. Patients being treated with levodopa, or any other dopamine D2-agonist
  11. 11. Patients who are pregnant or breast feeding
  12. 12. Patients with congenital long QT interval (QT) syndrome
  13. 13. Patients with a tumor of the anterior pituitary
  14. 14. Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks
  15. 15. Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
  16. 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. 17. Where local laws/regulations require: patients under legal protection

Contacts and Locations

Principal Investigator

Kumar Belani, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota Masonic Children's Hospital

Study Locations (Sites)

Helen Keller Hospital
Sheffield, Alabama, 35660
United States
Emory Healthcare - Emory University Hospital
Atlanta, Georgia, 30322
United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55455
United States
The Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States

Collaborators and Investigators

Sponsor: Acacia Pharma Ltd

  • Kumar Belani, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota Masonic Children'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 Registration Dates

Study Start Date2024-01-18
Study Completion Date2025-06-03

Study Record Updates

Study Start Date2024-01-18
Study Completion Date2025-06-03

Terms related to this study

Additional Relevant MeSH Terms

  • Nausea and Vomiting, Postoperative