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
  Purpose

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.


Condition Intervention Phase
Postoperative Nausea and Vomiting
Drug: 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, 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

Resource links provided by NLM:


Further study details as provided by Helsinn Healthcare SA:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 150
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 mcg/kg arm
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Drug: palonosetron
palonosetron IV 1 mcg/kg
Experimental: 3 mcg/kg arm
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
Drug: palonosetron
palonosetron 3mcg/kg IV

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828295

Locations
Russian Federation
Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care
Moscow, Russian Federation
Federal State Institution Central Research Institute of Traumatology and Orthopedics n.a. N.N. Priorov under the Federal Agency for High-Tech Medical Care
Moscow, Russian Federation
Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care
St. Petersburg, Russian Federation
State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"
St. Petersburg, Russian Federation
State Healthcare Institution 'Regional Pediatric Clinical Hospital'
Yaroslavl, Russian Federation
Ukraine
Cherkassy Regional Hospital, Pediatric Surgery Department
Cherkassy, Ukraine
Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department
Dnipropetrovsk, Ukraine
M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital
Donetsk, Ukraine
Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department
Ivano-Frankivsk, Ukraine
Specialized Children's Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department
Kyiv, Ukraine
Ukrainian Specialized Children's Hospital "OKHMATDYT", Anesthesiology and Intensive Care Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric Anesthesiology and Intensive Care Department
Kyiv, Ukraine
Ukrainian Specialized Children's Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department
Kyiv, Ukraine
Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine
Lviv, Ukraine
Sponsors and Collaborators
Helsinn Healthcare SA
  More Information

No publications provided

Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT00828295     History of Changes
Other Study ID Numbers: PALO-07-29
Study First Received: January 22, 2009
Results First Received: June 27, 2014
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Helsinn Healthcare SA:
Postoperative Nausea and Vomiting
palonosetron
pediatric

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Palonosetron
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014