NCT00365300已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 129 人开始时间: 2006年9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
- 129
- 主要终点
- Number of Patients Withdrawn From Study Due to Lack of Efficacy.
研究概览
简要总结
To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).
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
- 28 Days 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
- •clinical diagnosis of GERD
- •weight greater than 2.5 kg and less than or equal to 15 kg
排除标准
- •known history of upper GI anatomic disorders
- •history of acute life-threatening medical conditions
- •clinically significant medical conditions or laboratory abnormalities
研究组 & 干预措施
Pantoprazole
Active Comparator
干预措施: pantoprazole (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients Withdrawn From Study Due to Lack of Efficacy.
时间窗: 4 weeks double-blind
Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment.
次要结局
未报告次要终点
研究者
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