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A Multicenter, Parallel, Randomized, Double‐Blind, Placebo‐Controlled Trial with an Open‐Label Rescue Phase to Evaluate the Efficacy and Safety of Caffeine Citrate for Treatment of Apnea of Prematurity (AOP)

Trial Profile

A Multicenter, Parallel, Randomized, Double‐Blind, Placebo‐Controlled Trial with an Open‐Label Rescue Phase to Evaluate the Efficacy and Safety of Caffeine Citrate for Treatment of Apnea of Prematurity (AOP)

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Apr 2018

At a glance

  • Drugs Caffeine citrate (Primary) ; Caffeine citrate (Primary)
  • Indications Apnoea
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Roxane Laboratories
  • Most Recent Events

    • 19 Apr 2018 In this study (TGA document), 87 infants were randomized to two groups (46 were randomized to caffeine and 41 to placebo).Two patients did not receive drug and 3 were not included in the efficacy analysis because they had < 6 apnea episodes/24 hours at baseline.I have kept actual patient number as 87.
    • 19 Apr 2018 New trial record
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