NCT00219700已完成2 期
Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity
PLx Pharma0 个研究点目标入组 125 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 主要终点
- Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.
研究概览
简要总结
To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events
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
- Single
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
- •moderate osteoarthritis in the hip and/or knee requiring chronic pain medication
- •others per protocol
排除标准
- •sensitivity to NSAIDs and lecithin
- •hypertension
- •history of GI and other specific problems
- •use of medications and other criteria per the protocol
结局指标
主要结局
Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.
次要结局
- WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.
研究者
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