NCT00324974已完成3 期
A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Study Assessing the Safety and Efficacy of Lansoprazole Microgranules Oral Suspension in Infants With Symptomatic Gastroesophageal Reflux
Takeda0 个研究点目标入组 162 人开始时间: 2006年6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
- 162
- 主要终点
- Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment.
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules oral suspension, once daily (QD), in infants with gastroesophageal reflux symptoms during a 4-week treatment period.
详细描述
This study will be conducted by approximately 20 investigative sites in the U.S. and Poland. Participants who qualify will be randomized in equal proportions to receive either lansoprazole Pediatric Suspension (0.2-0.3 mg/kg/day in infants <10 weeks of age or 1.0-1.5 mg/kg/day in infants >10 weeks of age) or Placebo. This study consists of three periods: Pretreatment Period of 7-14 days, Double-Blind Treatment Period of 4 weeks (Dosing), and the Post-Treatment Period of 30 days (Follow-Up).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 7 days post-surgery at the time of Screening (Study Visit 1) with no anticipated need for surgery during the study.
- •Experiencing symptoms of gastroesophageal reflux disease (regurgitation, vomiting or "spitting up," fussing/irritability, feeding refusal, crying during feeding, arching back, poor weight gain, or extraesophageal manifestations) or endoscopy proven reflux disease.
- •Must continue to have reflux symptoms during the Pretreatment Period despite reducing or eliminating exposure to tobacco smoke, using one positioning and feeding strategy the last 7 days as documented in the Daily Diary.
- •The infant exhibited crying, fussing, or irritability during or within 1 hour of feeding in >25% of all feedings during the last 4 days of the Pretreatment Period as documented in the Daily Diary.
排除标准
- •Body weight <2.0 kilogram at Dosing Day 1 of the Double-Blind Treatment Period.
- •Unstable, congenital or acquired, clinically significant disease of any major organ system (cardiovascular, respiratory, renal, hepatic, metabolic, etc.), including suspected and/or documented culture-proven sepsis.
- •Coexisting esophageal disease (e.g., eosinophilic esophagitis, viral, bacterial or fungal infection) or caustic or physiochemical trauma to the esophagus.
- •Any congenital anomaly of the upper gastric intestinal tract that might interfere with gastrointestinal motility, pH, absorption, or active or known history of necrotizing enterocolitis that has been surgically corrected.
- •Use of a proton pump inhibitor within 30 days prior to Dosing Day
- •Use of H2 Blockers (i.e. Zantac) within 7 days prior to Dosing Day
- •Allergy to proton pump inhibitors (i.e. Prilosec, Prevacid).
- •Use of prokinetics (e.g., metoclopramide) unless on a stable dose for at least 3 days prior to entering the Pretreatment Period.
- •Unable to obtain stable drug levels after continuous treatment with required drugs including theophylline derivatives, digoxin, phenytoin, phenobarbital, or carbamazepine within the 7 days prior to Dosing Day
- •Clinically Significant abnormalities in clinical laboratory values.
研究组 & 干预措施
Lansoprazole QD
Experimental
干预措施: Lansoprazole microgranules suspension (Drug)
Placebo QD
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment.
时间窗: Week 4
Safety Assessments
时间窗: Baseline through week 8
次要结局
- Global Symptom Assessment, as answered by Investigator and Parent/Guardian(Baseline through Week 8)
- Sensitivity analyses of the primary endpoint(Week 4)
- Additional Daily Diary-based symptom Assessments(At the end of the double-blind treatment period and 30 days after the last dose of study drug.)
- Indicators of Growth Parameters(During and at the end of the Double-blind treatment period and 30 days after the last dose of study drug.)
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