NCT00626535已完成3 期
A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 500
- 主要终点
- To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 4 weeks of treatment in patients with sGERD
研究概览
简要总结
This study compares 4 weeks of treatment with Esomeprazole 20 mg once daily to Placebo in the treatment of Upper Abdominal Pain in patients with Symptomatic Gastroesophageal Reflux Disease (sGERD)
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
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of episodes of heartburn and upper abdominal pain for 6 months or longer.
- •Episodes of heartburn 2 or more days during the 7 days prior to the screening visit. Moderate or severe upper abdominal pain on at least 3 out of the 7 consecutive days of the run-in period.
- •A normal endoscopy within 14 days of Visit 1 of between Run-in and randomization.
排除标准
- •Subjects with pain likely to be due to irritable bowel syndrome (IBS)
- •History of esophageal, gastric or duodenal surgery, except for closure of an ulcer.
- •History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- •Further diseases / conditions, as listed in the protocol.
研究组 & 干预措施
1
Experimental
20mg once daily
干预措施: Esomeprazole (Drug)
2
Placebo Comparator
Oral once daily
干预措施: Matching placebo (Drug)
结局指标
主要结局
To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 4 weeks of treatment in patients with sGERD
时间窗: Daily diary cards completed by the patient
次要结局
- To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 1, 2, and 4 weeks of treatment in patients with sGERD(Daily diary cards completed by the patient)
- To demonstrate a difference in percentage of days with, days to resolution of, and severity of upper abdominal pain through 4 weeks of treatment between esomeprazole 20 mg once daily and placebo qd in patients with sGERD(Percentage of days without upper abdominal pain over the 4-week treatment period)
- To assess the safety and tolerability of esomeprazole 20 mg qd through 4 weeks of treatment.(Mean severity of the patient's upper abdominal pain over the last 4 weeks.)
研究者
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