A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 43
- 主要终点
- Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
研究概览
简要总结
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to undergo endoscopy with required biopsy
- •Ages 1 through 5 years
- •Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.
排除标准
- •History or presence of upper gastrointestinal anatomic or motor disorders
- •Known current or active cow's milk allergy
- •Malignancy
- •Other exclusions apply.
研究组 & 干预措施
3
High Dose Pantoprazole (Approximately 1.2 mg/kg)
干预措施: pantoprazole sodium enteric-coated spheroid (Drug)
2
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
干预措施: pantoprazole sodium enteric-coated spheroid (Drug)
1
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
干预措施: pantoprazole sodium enteric-coated spheroid (Drug)
结局指标
主要结局
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
时间窗: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, and Final Week
Weekly GERD symptom score (WGSS) is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final Week was defined as the last 7 days of symptom scores collected during the treatment period.
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
时间窗: Baseline and 8 weeks
WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period.
次要结局
- Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week(Baseline and 8 weeks)
- Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline(Baseline and 8 weeks)
- Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study(8 weeks)