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

17. marts 2015 opdateret af: Helsinn Healthcare SA

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

150

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
        • 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, Den Russiske Føderation
        • Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care
      • St. Petersburg, Den Russiske Føderation
        • Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care
      • St. Petersburg, Den Russiske Føderation
        • State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"
      • Yaroslavl, Den Russiske Føderation
        • State Healthcare Institution 'Regional Pediatric Clinical Hospital'
  • Ukraine
      • Cherkassy, Ukraine
        • Cherkassy Regional Hospital, Pediatric Surgery Department
      • Dnipropetrovsk, Ukraine
        • Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department
      • Donetsk, Ukraine
        • M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital
      • Ivano-Frankivsk, Ukraine
        • Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department
      • Kyiv, 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
      • Lviv, Ukraine
        • Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

4 uger til 16 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1 mcg/kg arm
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Medicin: palonosetron
palonosetron IV 1 mcg/kg
Medicin: palonosetron
palonosetron 3mcg/kg IV
Eksperimentel: 3 mcg/kg arm
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
Medicin: palonosetron
palonosetron IV 1 mcg/kg
Medicin: palonosetron
palonosetron 3mcg/kg IV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
Tidsramme: 0-72 hours post-operatively
0-72 hours post-operatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Patients With Complete Response 0-24 Hours
Tidsramme: 0-24 hours
Complete Response defined as no vomiting, no retching, and no use of rescue medication
0-24 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Helsinn Healthcare SA

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2008

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. januar 2009

Datoer for studieregistrering

Først indsendt

22. januar 2009

Først indsendt, der opfyldte QC-kriterier

22. januar 2009

Først opslået (Skøn)

23. januar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. marts 2015

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PALO-07-29

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med palonosetron

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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