CTRI/2009/091/000882已完成3 期
A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Lont-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1- to 11-Year Old Pediatric Subjects With Endoscopically Proven GERD. - Nil
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •History of at least 1 GERD symptom within 3 months of screening
- •Positive esophagogastroduodenoscopy
- •Signed informed consent
- •Female patients (if menstruating) must be practicing birth control
排除标准
- •Patients with history of esophagitis
- •Patients who have milk protein allergy
- •Patients who have taken Proton Pump Inhibitors or H2-blockers within 3 days
- •Patients who have taken sucralate or any medication that affects gastrointestinal motility
- •Patients with H. pylori
- •Patients with lab values outside the normal age appropriate range
- •Patients who have participated in another trial within 30 days before screening
- •Patients with allergies to Proton Pump Inhibitors
研究者
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A Multicenter, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1-to-11-Year-Old Pediatric Subjects with Endoscopically Proven GERDEndoscopically proven gastroesophageal reflux disease (GERD) in a paediatric population of 1 to 11 year old subjects.MedDRA version: 9.1Level: LLTClassification code 10018203Term: GERDEUCTR2008-004837-54-BEJanssen-Cilag International NV100
进行中（未招募）
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A Multicenter, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1-to-11-Year-Old Pediatric Subjects with Endoscopically Proven GERDEUCTR2008-004837-54-DKJanssen-Cilag International NV100
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A Multicenter, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1-to-11-Year-Old Pediatric Subjects with Endoscopically Proven GERDEndoscopically proven gastroesophageal reflux disease (GERD) in a paediatric population of 1 to 11 year old subjects.MedDRA version: 9.1Level: LLTClassification code 10018203Term: GERDEUCTR2008-004837-54-FRJanssen-Cilag International NV127
进行中（未招募）
不适用
A Multicenter, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1-to-11-Year-Old Pediatric Subjects with Endoscopically Proven GERDEUCTR2008-004837-54-BGJanssen-Cilag International NV100
进行中（未招募）
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A Multicenter, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1-to-11-Year-Old Pediatric Subjects with Endoscopically Proven GERDEndoscopically proven gastroesophageal reflux disease (GERD) in a paediatric population of 1 to 11 year old subjects.MedDRA version: 9.1Level: LLTClassification code 10018203Term: GERDEUCTR2008-004837-54-NLJanssen-Cilag International NV100