Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of R051619 (Cisapride Oral Suspension 0.2 mg/kg q.i.d.) for the Treatment of Symptomatic Gastro-Oesophageal Reflux Disease (GORD) in Infants and Children
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Caregiver's assessment of infant pediatric GORD symptoms
研究概览
简要总结
The purpose of this study is to compare the efficacy and tolerability of cisapride with placebo in infants and children with gastro-oesophageal reflux disease (GORD).
详细描述
This is a double-blind (neither patient nor study staff will know the identity of the assigned treatment) study evaluate the effectiveness and safety of cisapride in patients with gastro-oesophageal reflux disease (GORD) (also referred to as gastroesophageal reflux disease [GERD[) compared to a placebo (a identical in appearance to cisapride but does not contain active drug). Patients will receive placebo or cisapride suspension at 0.2 mg/kg (volumn determined by patient weight) four times per day (q.i.d.) (15 minutes before feeding 3 times a day and at bedtime) orally (by mouth) for 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of GORD based on protocol-specified characteristics
- •Failed the 1st of 5 stepwise treatments for GORD recommended by the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)
- •Caregiver able to complete the I-GERQ-R questionnaire
排除标准
- •Protocol-specified respiratory conditions requiring previous or current treatment with oral or intravenous corticosteroids (prior and concurrent use of inhaled corticosteroids is acceptable)
- •Cause of vomiting/regurgitation other than GORD
- •Prior history of cisapride intake
研究组 & 干预措施
001
Cisapride 0.2 mg/kg suspension q.i.d.for 8 weeks.
干预措施: Cisapride (Drug)
002
Placebo Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Caregiver's assessment of infant pediatric GORD symptoms
时间窗: Up to 8 weeks (56 days)
次要结局
- The number and type of adverse events reported(From time of first dose to the last dose (up to 8 weeks))