NCT01408173已完成3 期
A Phase III Clinical Study of NPC-11 in the Treatment of Apnea of Prematurity. - Investigation of Safety, Efficacy and Pharmacokinetics of Caffeine Citrate -
Nobelpharma3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Success rates for controlling of apnea episode in each observation day (at least 50% reduction of apnea episodes from baseline)
研究概览
简要总结
The aim of the present Phase III study is to evaluate the safety, efficacy and pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postconceptional age between 28 weeks and 33 weeks, and over 24 hours after birth.
- •At least 6 episodes of apnea (>20 seconds in duration) in 24 hours.
- •Signed written informed consent from parent(s) or legal guardian(s).
排除标准
- •Apnea due to: hypoxic-ischemic encephalopathy, meningitis, seizures, Grade III or IV intracranial hemorrhage, CNS depression from drugs administered to the mother during delivery, periventricular leukomalacia, pneumonia which does not improve even if it treats, hemoglobin< 10 g/dL, sepsis, shock which does not improve even if it treats, blood pH<7.2 on 2 consecutive determinations in spite of correction, serum calcium concentration <7.0 mg/dL which does not improve even if it treats, serum glucose concentration <4.0 mg/dL which does not improve even if it treats, congestive heart failure, symptomatic patent ductus arteriosus, rectal temperature>38.5 °C on 2 consecutive readings, rectal temperature< 35 °C on 2 consecutive readings, obstructive apnea.
- •Blood urea nitrogen >20 mg/dL, serum creatinine >1.5 mg/dL.
- •Serum AST or ALT >3 times the upper limit of normal.
- •Requirement of mechanically-assisted ventilation ( containing nasal CPAP, nasal DPAP).
- •Previous treatment with methylxanthines within 7 days prior to study enrollment.
- •Previous treatment with H2 antagonists (i.e., cimetidine or ranitidine) within 7 days prior to study enrollment.
- •Receiving or experiencing the effects of CNS-active medication at the time of enrollment.
- •Participant of other clinical trial within 6 months.
- •Inappropriate to enter this clinical trial judged by the investigator in charge.
研究组 & 干预措施
NPC-11
Experimental
- Loading Dose (Day 1): Caffeine citrate 20 mg/kg body weight will be administered intravenously using a syringe infusion pump over 30 minutes.
- Maintenance Dose (Day 2～Day 10): After an interval 24 hours, caffeine citrate 5 mg/kg body weight will be administered intravenously (over 10 minutes) or orally if the patients will be able to receive oral administration once a day. The maintenance dose can be increased to a maximum 10 mg/kg caffeine citrate once a day if apnea persists.
干预措施: NPC-11 for intravenous or oral administration. (Drug)
结局指标
主要结局
Success rates for controlling of apnea episode in each observation day (at least 50% reduction of apnea episodes from baseline)
时间窗: 1, 2, 3, 4, 5, 6,7, 8, 9 and 10 day
次要结局
- The change of frequency of apnea episode from baseline in each observation day(1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day)
- Time to event：Days until next events occurred(1 to 10 day)
- The change of average duration time of apnea episode from baseline in each observation day(1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day)
- The change of lowest oxygen saturation during apnea episodes from baseline in each observation day(1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day)
- The proportion of less than 85% oxygen saturation during apnea episodes in each observation day(1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day)
研究者
研究点 (3)
Loading locations...
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