A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multi-center Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Neonates With Clinically-Evident Gastroesophageal Reflux Disease.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Mean Intragastric 24 hour pH (subset of six subjects)
研究概览
简要总结
The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.
详细描述
A Phase 1, multi-center, pharmacokinetic/pharmacodynamic and safety, study in which neonates will be randomized in an open-label fashion to receive 5 days of open-label treatment with either lansoprazole pediatric suspension 1.0 mg/kg/day orally or lansoprazole pediatric suspension .5 mg/kg/day orally. On dosing Days 1 and 5, blood samples will be obtained for drug assay. All subjects will be evaluated for inclusion in the pH monitoring portion of the study and will undergo pH monitoring, provided it is clinically indicated, at the discretion of the investigator. Intragastric pH monitoring (up to 24 hours) will be performed at baseline, on dosing Day 1 (or Day 2) and on dosing Day 5 (or Day 6). Intraesophageal pH may be done in addition to intragastric pH at the discretion of the investigator. Subjects will be evaluated for safety, including a follow-up visit on post-dosing Day 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates in the Neonatal Intensive Care or Special Care Nursery who have been fed orally or by feeding tube.
- •Term or post-term infants with a body weight of >800 gms.
- •Pre-term infants with a corrected age of less than 44 weeks.
- •Clinically-evident GERD (feeding intolerance, regurgitation, wheezing or stridor with feedings)
- •At least 7 days post-surgery without anticipated need for surgery during study
- •No significant laboratory abnormalities
排除标准
- •Unstable, clinically significant disease or abnormality
- •Congenital anomaly of the upper gastrointestinal tract
- •Clinical evidence of acute sepsis
- •Cystic fibrosis
- •Medical condition requiring subject to not be fed by mouth/gastric tube
研究组 & 干预措施
Lansoprazole 0.5 mg/kg QD
干预措施: Lansoprazole (Drug)
Lansoprazole 1.0 mg/kg QD
干预措施: Lansoprazole (Drug)
结局指标
主要结局
Mean Intragastric 24 hour pH (subset of six subjects)
时间窗: Day -1, Day 1 and Day 5
Pharmacokinetic Analysis
时间窗: Day 1 and 5
次要结局
- Gastroesophageal Reflux Disease Symptom Analysis(Days 1-5)