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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy (endoscopic/histological healing) and safety of 2 dose levels (0.5 mg/kg and 1.0 mg/kg) of a pediatric bead formulation in a 12 week design followed by long-term safety and efficacy assessment in a 24-week maintenance study.
研究概览
简要总结
The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the treatment of acid-related disorders in pediatric patients, focusing specifically on the manifestation of GERD (symptomatic and erosive types).This is a randomized, double-blind study that consists of two parts. In Part 1, the study will consist of 3 phases: a 14-day screening phase, a double-blind treatment phase of 12 weeks comparing two doses of study drug (0.5 mg/kg or 1.0 mg/kg groups based on patient's body weight), and an end-of-study or early withdrawal phase followed by Part 2, which consists a of double-blind treatment continuation for patients who have achieved healing during the short-term double-blind treatment phase. The double-blind maintenance treatment phase lasts for not more than 24 weeks and is concluded by an end-of-study/early withdrawal visit. Oral rabeprazole 2.5 capsules or 5 mg capsules, given once daily at a dose of 0.5 mg/kg or 1.0 mg/kg; short-term treatment phase is 12 weeks; long-term maintenance treatment phase is 24 weeks. Target sample size for India is 8 and the date of first enrollment in India is January 28, 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
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 rangePatients who have participated in another trial within 30 days before screening Patients with allergies to Proton Pump Inhibitors.
结局指标
主要结局
Evaluate the efficacy (endoscopic/histological healing) and safety of 2 dose levels (0.5 mg/kg and 1.0 mg/kg) of a pediatric bead formulation in a 12 week design followed by long-term safety and efficacy assessment in a 24-week maintenance study.
时间窗: Evaluate the efficacy (endoscopic/histological healing) and safety of 2 dose levels (0.5 mg/kg and 1.0 mg/kg) of a pediatric bead formulation in a 12 week design followed by long-term safety and efficacy assessment in a 24-week maintenance study.
次要结局
- Evaluate changes from baseline of endoscopic and histological grade, the percentage of patients with improvement in pH>4; changes in weekly average GERD scores and symptoms(Evaluate changes from baseline of endoscopic and histological grade, the percentage of subjects with improvement in pH>4; changes in weekly average GERD scores & symptoms)