A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)
研究概览
简要总结
The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.
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 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)
- •patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams
排除标准
- •patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)
- •patients with a history of acute life-threatening event
研究组 & 干预措施
Open Label Esomeprazole
This is an open label, run-in phase. All patients received Esomeprazole.
干预措施: Open Label Run In Esomeprazole (Drug)
Double Blind Esomeprazole
This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.
干预措施: Double Blind Esomeprazole (Drug)
Double Blind Placebo
This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.
干预措施: Double Blind Placebo (Drug)
结局指标
主要结局
Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)
时间窗: Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.
次要结局
- Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint)(Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study))
- Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)(Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study))
- Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint).(Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study))
- Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)(Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained)
- Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)(Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained)
- Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)(Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained)
- Severity of Feeding Difficulties Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)(Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained)
- Improvement in Physician's Global Assessment (PGA) Following Open-label Esomeprazole (Open-label Phase Endpoint)(Open-label treatment period (2 weeks))
- Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Open-label Phase)(Open Label phase (Screening plus two weeks))
- Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Open-label Phase Endpoint)(Open Label Phase (Screening plus two weeks))
- Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Open-label Phase Endpoint)(Open Label Phase (Screening plus two weeks))
- Severity of Feeding Difficulties as Reported by Parent/Guardian (Open-label Phase Endpoint)(Open Label Phase (Screening plus two weeks))