A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Emetogenic Chemotherapy Sub-title: Open-Label Cohort to Further Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients Birth to <12 Years Old

Trial Profile

A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Emetogenic Chemotherapy Sub-title: Open-Label Cohort to Further Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients Birth to <12 Years Old

Completed
Phase of Trial: Phase II

Latest Information Update: 04 Apr 2017

At a glance

  • Drugs Fosaprepitant (Primary) ; Ondansetron
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Merck & Co; Merck Sharp & Dohme
  • Most Recent Events

    • 04 Dec 2016 Status changed from active, no longer recruiting to completed.
    • 21 Jul 2016 The trial was completed in Germany.
    • 11 May 2016 This trial is temporarily halted in Spain and completed in Austria and Lithuania, according to the European Clinical Trials Database.
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