NCT00251914已完成3 期
Supportive Test for Acid-Related Symptoms (STARS I) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Subjects With Upper Gastrointestinal Symptoms and With Normal Findings at Esophagogastroduodenoscopy.
适应症
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
- 1,500
- 试验地点
- 215
- 主要终点
- The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
研究概览
简要总结
The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment.
- •Both Helicobacter pylori positive and negative patients eligible (Helicobacter pylori is a bacterial infection of the stomach)
排除标准
- •Presence of clinical significant abnormal findings at the endoscopy (examination of esophagus and stomach) prior to enrollment.
- •Patients with symptoms of other gastrointestinal diseases, such as Gastroesophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD).
- •Helicobacter pylori eradication treatment during the last 12 months prior to enrollment.
结局指标
主要结局
The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).
The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.
次要结局
- Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy
- The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,
- The average symptom score and the percentage of symptom-free days during the 7-week treatment period,
研究者
研究点 (215)
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