NCT00241540已完成3 期
Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo & Esomeprazole 20 mg Once Daily Versus Placebo in Treatment for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs
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
- 808
- 试验地点
- 119
- 主要终点
- To assess the efficacy of esomeprazole versus placebo through 4 weeks of treatment of upper GI symptoms associated with nonsteroidal anti-inflammation
研究概览
简要总结
This study is a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs. placebo and esomeprazole 20 mg orally qd vs. placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a period of 4 weeks in treatment of relief of upper GI symptoms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age, or older.
- •Capable of completing the diary card.
- •Ability to complete the HRQL questionnaires.
- •A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months.
- •Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (>325 mg/day).
- •Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally).
排除标准
- •Current, or history of, gastric or duodenal ulcer
- •Current, or history of, esophageal, gastric or duodenal surgery.
- •History of GERD, not associated with NSAID use.
- •Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
- •Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
- •Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus
结局指标
主要结局
To assess the efficacy of esomeprazole versus placebo through 4 weeks of treatment of upper GI symptoms associated with nonsteroidal anti-inflammation
次要结局
- - To assess the safety & tolerability of esomeprazole versus placebo when administered for up to 4 weeks to patients receiving daily NSAID therapy
- - To assess the impact of treatment
研究者
研究点 (119)
Loading locations...
相似试验
已完成
3 期
Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDsNSAIDsUpper GI SymptomsNCT00241527AstraZeneca556
已完成
3 期
Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDsNSAIDsUpper GI SymptomsNCT00241553AstraZeneca276
已完成
3 期
Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDsGERDNCT00241514AstraZeneca334
已完成
3 期
Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)Gastric UlcerDuodenal UlcerNCT00441727AstraZeneca2,426
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)Symptomatic Gastroesophageal Reflux Disease (sGERD)NCT00626535AstraZeneca500