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NPC-11 Phase III Trial Concerning Apnea of Prematurity in Japanese Neonates: A Study of Safety, Efficacy and Pharmacokinetics

Masatoshi Kondo, Hiroyuki Kitajima, Toshio Yamazaki, Mitsuo Ohzeki and Susumu Itoh

Objective: To study the safety, efficacy, and pharmacokinetics of caffeine citrate in the treatment of apnea of prematurity in Japanese neonates. Study design: A non-blind, uncontrolled, multicenter, collaborative clinical trial. Setting: Three neonatal intensive care units in Japan Patient inclusion criteria: Neonates at the post conceptional age of 28 weeks to 33 weeks who were diagnosed with apnea of prematurity. Main outcome measures: 50% or greater reduction in apneic episodes, adverse effects, and pharmacokinetics. Method: Day 1 - Intravenous (IV) administration of caffeine citrate loading dose of 20 mg/kg, administered over 30 minutes. From day 2 onward - Commencement of administration of maintenance dose (caffeine citrate dose of 5 mg/kg) once daily intravenously over 10 minutes or orally. In the case that event incidence was reduced, the maintenance dose continued to be administered until day 10. If the doctor judged the initial maintenance dose to be ineffective, or its efficacy to be insufficient, the maintenance dose was raised to 10 mg/kg/day. Results: 23 patients fitting the specifications were found, and dosing was commenced. The reduction rate in apneic episodes during the trial was from 43.5% to 60.9%. Severe adverse effects were not noted. Mean serum concentration was maintained within the therapeutic range, between 11.87 and 18.82 mg/L. Data from clinical trials (Study OPR-001) in the United States, which were similar in methodology to this trial, were used when analyzing population pharmacokinetics. No difference due to race Conclusion: Caffeine citrate dosing for treatment of apnea of prematurity was effective, produced no safety problems, and showed good tolerability. Additionally, no differences between Japanese and Americans with regard to efficacy, safety and pharmacokinetics were observed Identifier of this clinical trial: NCT01408173