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:
NCT00828295
First received: January 22, 2009
Last updated: July 28, 2014
Last verified: July 2014

January 22, 2009
July 28, 2014
August 2008
December 2008   (final data collection date for primary outcome measure)
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively [ Time Frame: 0-72 hours post-operatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00828295 on ClinicalTrials.gov Archive Site
Proportion of Patients With Complete Response 0-24 Hours [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
Complete Response defined as no vomiting, no retching, and no use of rescue medication
  • Proportion of patients with no emetic episodes in different time periods [ Time Frame: 0-6 hours, 6-24 hours, 24-48 hours, 48-72 hours, 0-24 hours, 0-48 hours and 24-72 hours ] [ Designated as safety issue: No ]
  • Severity of nausea (only for patients aged 6 up to 16 years inclusive) in different time periods [ Time Frame: 0-6 hours, 6-24 hours, 24-48 hours, and 48-72 hours; and at the overall time period (0-72 hours) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
A Multicenter, Double-blind, Randomized, Parallel Group, Stratified Study to Assess the Safety and Efficacy of Single IV Doses of Palonosetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Postoperative Nausea and Vomiting
  • Drug: palonosetron
    palonosetron IV 1 mcg/kg
  • Drug: palonosetron
    palonosetron 3mcg/kg IV
  • Experimental: 1 mcg/kg arm
    Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
    Intervention: Drug: palonosetron
  • Experimental: 3 mcg/kg arm
    Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
    Intervention: Drug: palonosetron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
January 2009
December 2008   (final data collection date for primary outcome measure)

MAIN INCLUSION CRITERIA

  • Male or female patient aged more than 28 days (full term) up to and including 16 years.
  • Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:

    • ear, nose and throat surgery;
    • eye surgery;
    • orchidopexy;
    • plastic reconstructive surgery;
    • herniorraphy;
    • orthopedic surgery).
  • American Society of Anesthesiologists (ASA) physical status I, II or III.
  • Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
  • Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery
  • For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.

MAIN EXCLUSION CRITERIA

  • For infant aged more than 12 months: a history of gastro-esophageal reflux.
  • For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.
  • Patient scheduled to undergo emergency surgery.
  • Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.
  • Patient scheduled to receive propofol during the maintenance phase of anesthesia.
  • Patient with vomiting from any organic cause.
  • Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.
  • Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.
Both
up to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Ukraine,   Russian Federation
 
NCT00828295
PALO-07-29
No
Helsinn Healthcare SA
Helsinn Healthcare SA
Not Provided
Not Provided
Helsinn Healthcare SA
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP