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

NCT00828295 | Completed Phase 3 Results

• 1 other identifier: PALO-07-29
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 13

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and Vomiting; palonosetron; pediatric

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively

  0-72 hours post-operatively

Secondary Outcomes (1)

• Proportion of Patients With Complete Response 0-24 Hours

  0-24 hours

Study Arms (2)

1 mcg/kg arm

EXPERIMENTAL

Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)

Drug: palonosetron

3 mcg/kg arm

EXPERIMENTAL

Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)

Drug: palonosetron

Interventions

palonosetron DRUG

palonosetron IV 1 mcg/kg

1 mcg/kg arm

Eligibility Criteria

• Age: 28 Days - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsinn Healthcare SA: lead

Study Sites (13)

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, Russia

Location

Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care

Moscow, Russia

Location

Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care

Saint Petersburg, Russia

Location

State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"

Saint Petersburg, Russia

Location

State Healthcare Institution 'Regional Pediatric Clinical Hospital'

Yaroslavl, Russia

Location

Cherkassy Regional Hospital, Pediatric Surgery Department

Cherkassy, Ukraine

Location

Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department

Dnipropetrovsk, Ukraine

Location

M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital

Donetsk, Ukraine

Location

Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department

Ivano-Frankivsk, Ukraine

Location

Specialized Children's Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department

Kyiv, Ukraine

Location

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

Location

Ukrainian Specialized Children's Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department

Kyiv, Ukraine

Location

Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine

Lviv, Ukraine

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Salvatore Chessari
• Organization: Helsinn Healthcare SA

salvatore.chessari@helsinn.com

+41 91 985 21 21

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: August 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: April 3, 2015
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

RU (5); UA (8)