NCT01670552已完成3 期
Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients.
EMS1 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2016年2月17日最近更新:
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
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
研究概览
简要总结
The purpose of this study is to evaluate the safety of an association with one anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.
详细描述
- Double-blind,randomized, multicenter
- Experiment duration: 14 days
- 03 visits
- Evaluate the safety of an association with one anti-inflammatory and one gastroprotective compared to association with one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation
- Adverse events evaluation
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults male or female aged ≥ 18 years old;
- •Comply with all the purposes and procedures of the study by signing and dating the Informed Consent.
- •Acute or chronic osteo-articular injury in need of of anti-inflammatory for a period of 14 days.
排除标准
- •Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period
- •History of peptic ulcer or gastric surgery;
- •Use of Non-steroidal anti-inflammatory (NSAIDs), aspirin, proton pump inhibitor (PPIs), H2 blocker and antacid in the past 7 days;
- •Contraindication to the use of NSAIDs or PPIs;
- •Renal or hepatic impairment;
研究组 & 干预措施
Naproxen + Esomeprazole
Active Comparator
Naproxen + Esomeprazole - 1 tablet each 12 hours for 14 days
干预措施: Naproxen + Esomeprazole (Drug)
Nimesulide + Pantoprazole
Experimental
Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days
干预措施: Nimesulide + Pantoprazole (Drug)
结局指标
主要结局
Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
时间窗: 14 days
次要结局
- Incidence of adverse events and dyspeptic complaints during the study(14 days)
研究者
研究点 (1)
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