NCT00241501已完成3 期
A Phase III, Multicentre, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 140
- 试验地点
- 40
- 主要终点
- To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients
研究概览
简要总结
This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.
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
- Double
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed written informed consent from the patient's parent/guardian, and assent from the patient prior to conducting of any study-related procedures.
- •Patients must be male or female between the age of 12 and 17 years, inclusive.
- •Patients must have a clinical diagnosis of GERD made by the investigator based on any of the following factors: history, physical examination, review of systems, laboratory test results, or information from diagnostic testing.
排除标准
- •Patients who have used a PPI within 14 days prior to randomization, including over-the-counter Prilosec®.
- •Patients who have used any prescription or over-the-counter treatment for symptoms of gastroesophageal reflux disease (GERD), such as Histamine 2 Receptor Antagonists (H2RA) or prokinetics, within 3 days prior to randomization. Antacids may be used, except for those containing bismuth.
- •Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
结局指标
主要结局
To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients
12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G
次要结局
- To evaluate the clinical outcome of once daily treatment with esomeprazole in relieving gastroesophageal reflux disease (GERD)-associated signs & symptoms in pediatric & adolescent patients 12 to 17 years of age
- - Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.
- - Assessment of changes from baseline in Physician Global Assessment.
研究者
研究点 (40)
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