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)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 19 Apr 2018
Price :
$35
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At a glance
- Drugs Caffeine citrate (Primary) ; Caffeine citrate (Primary)
- Indications Apnoea
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Roxane Laboratories
- 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