NCT00241514已完成3 期
Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo or Esomeprazole 20 mg Once Daily Versus Placebo in Prevention 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
- 334
- 试验地点
- 113
- 主要终点
- To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d.
研究概览
简要总结
This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess the efficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.
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
- •Signed informed consent.
- •Completed the SH-NEN-0001 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
- •A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 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 NSAIDs.
- •Daily NSAID treatment dose and type: (Must have been stable for at least 9 weeks prior to inclusion and; Are expected to remain stable for the duration of the study. and; Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally).
- •Hp negative on Histology performed at baseline endoscopy in the study SHNEN- 0001.
排除标准
- •Discontinuation from study SH-NEN-0001
- •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.
- •Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.
- •Need for continuous concomitant therapy with: (Anticoagulants; Corticosteroids at doses higher than explained under inclusion criterion)
结局指标
主要结局
To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d.
and 20 mg q.d. versus placebo orally q.d. through 6 months of treatment for the
prevention of relapse of upper GI symptom associated with NSAID use in patients
receiving daily NSAID therapy.
次要结局
- To assess the safety and tolerability of esomeprazole 40 mg orally q.d. versus placebo orally q.d. and 20 mg orally q.d. versus placebo orally q.d. when administered for 6 months to patients receiving daily NSAID therapy.
研究者
研究点 (113)
Loading locations...
相似试验
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 Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDsNSAIDsUpper GI SymptomsNCT00241527AstraZeneca556
已完成
3 期
Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDsGERDNCT00241540AstraZeneca808
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