NCT00971581已完成3 期
Safety, Tolerability and Efficacy of FDC Ketoprofen + Omeprazole in Patients With Rheumatological Conditions With History or Who Are at Risk of Developing NSAID Associated Benign Gastric Ulcers, Duodenal Ulcers and Gastroduodenal Erosions
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
- Sanofi
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To confirm the efficacy of the combination
研究概览
简要总结
Primary Objective:
To confirm the safety and tolerability of the fixed dose combination of a Non-Steroidal Anti-Inflammatory Drug (NSAID), ketoprofen, associated to a Proton Pump Inhibitor (PPI), omeprazole, in Mexican patients.
Secondary Objective:
To confirm the efficacy of the combination:
- Relief of pain (Visual Analyzed Score (VAS))
- Patients global assessment of disease activity, scored as a scale of 1 (no limitation of normal activities) to 5 (inability to carried out all normal activities)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FDC KETOPROFEN+OMEPRAZOLE
Experimental
One capsule of Ketoprofen 200 mg + Omeprazole 20 mg FDC once daily Treatment duration: 4 weeks
干预措施: FDC KETOPROFEN+OMEPRAZOLE (Drug)
结局指标
主要结局
To confirm the efficacy of the combination
时间窗: From the start to the end of the study (D 0 to D 28)
Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea
时间窗: At Day 10
次要结局
- Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea(At Day 0, Day 4 & Day 28)
- Incidence of complications (perforations, ulcers, bleeding) and Incidence of fecal occult blood positivity(At study termination (Day 28))
- Improvement of pain (VAS)(At study termination (Day 28))
- Incidence of moderate to severe abdominal symptoms and GastroIntestinal Adverse Event leading to withdrawal(From the start to the end of the study (D 0 to D 28))
- Patient's global assessment of disease activity, scored as a scale of 1 (no limitation of normal activities) to 5 (inability to carried out all normal activities)(At study termination (Day 28))
研究者
研究点 (1)
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