Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helsinn Healthcare SA
ClinicalTrials.gov Identifier:
NCT01395901
First received: July 14, 2011
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.


Condition Intervention Phase
Postoperative Nausea and Vomiting
Drug: Palonosetron
Drug: Ondansetron
Drug: Placebo to Ondansetron
Drug: Placebo to Palonosetron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients.

Resource links provided by NLM:


Further study details as provided by Helsinn Healthcare SA:

Primary Outcome Measures:
  • proportion of patients with Complete Response (no vomiting, no retching, and no use of rescue medication) during the first 24 hours after Time 0 (T0) [ Time Frame: 0-24 hours after T0 ] [ Designated as safety issue: No ]
    Time 0 (T0) is defined as the time when the patient wakes up and is able to show any active reaction postoperatively


Secondary Outcome Measures:
  • Other efficacy endpoints: [ Time Frame: 0-24 hours after T0 Time 0 (T0) is defined as the time when the patient wakes up and is able to show any active reaction postoperatively ] [ Designated as safety issue: No ]
    • Proportion of patients with no vomiting
    • Proportion of patients without emetic episodes
    • Proportion of patients without antiemetic rescue medication
    • Proportion of patients without nausea (patient aged > 6years)
    • Time to first vomiting
    • Time to first emetic episode
    • Time to first administration of rescue medication
    • Time to treatment failure (time to first emetic episode or time to first administration of rescue medication, whichever occur first)


Enrollment: 670
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palonosetron and placebo to Ondansetron
Intervention: Drug: Palonosetron
Drug: Palonosetron
Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Drug: Placebo to Ondansetron
Active Comparator: Ondansetron and placebo to Palonosetron
Intervention: Drug: Comparator: Ondansetron
Drug: Ondansetron

Single dose Ondansetron IV:

  • 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;
  • 13 years to less than 17 years dose: 4 mg
Drug: Placebo to Palonosetron

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patient aged from full term neonate to less than 17 years.
  • In-patient or out-patient scheduled to undergo one of the following procedures:

    • ear, nose and throat surgery (e.g., tonsillectomy, adenoidectomy, myringotomy),
    • eye surgery (e.g. strabismus, vitreoretinal, cataract surgery),
    • urological surgery (e.g. orchidopexy, varicocoele),
    • plastic reconstructive surgery (e.g. cleft lip/cleft palate, burn procedures involving the scalp),
    • hernia repair,
    • orthopedic surgery (e.g. foot and ankle deformities, arthroscopic surgeries, ACL surgery),.
    • cardiac surgery,
    • neurosurgery.
  • Patient is scheduled to undergo surgery requiring general intravenous anesthesia
  • Patient is scheduled to receive nitrous oxide during the maintenance phase of anesthesia
  • Patient weighs at least 3.2 kg
  • ASA physical status I, II or III
  • Fertile patients (male or female) must use reliable contraceptive measures
  • Female patients who have attained menarche must have a negative pregnancy test at the screening visit (Visit 1) and at study treatment visit (Visit 2)
  • For patients with known hepatic impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study
  • For patients with known renal impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study

Exclusion Criteria:

  • Lactating females
  • Patient aged ≤6 years who received any investigational drug within 90 days prior to Day 1, or patient aged >6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion.
  • Patient having participated in any previous trial with palonosetron.
  • History of allergy to any components or any other contraindications to the use of any 5-HT3 receptor antagonists
  • Patient to undergo emergency surgery
  • Patient scheduled to receive regional anesthesia (lumbar, epidural, spinal) alone or in conjunction with general intravenous anesthesia
  • Patient scheduled to receive laryngeal mask anesthesia
  • Patient scheduled to receive propofol during the maintenance phase of anesthesia
  • Patient suffering from any concomitant disease uncontrolled by therapy, which, in the judgment of the Investigator, could compromise the outcome of surgery
  • Patient with history of gastro-esophageal reflux (except for patients up to 12 months)
  • Patient with ongoing vomiting from any organic cause
  • Patient having experienced any vomiting, retching, or nausea within 24 hours prior to the administration of the study drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395901

  Show 44 Study Locations
Sponsors and Collaborators
Helsinn Healthcare SA
  More Information

No publications provided

Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT01395901     History of Changes
Other Study ID Numbers: PALO-10-14
Study First Received: July 14, 2011
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: State Institute for Drug Control
Ukraine: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Argentina: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Helsinn Healthcare SA:
Prevention of Postoperative Nausea and Vomiting
Palonosetron
Ondansetron
Pediatric

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Palonosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on April 22, 2014