NCT01801735已完成3 期
A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 主要终点
- Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
研究概览
简要总结
The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is male or female ≥ 40 years of age
- •If a participant in the previous MEL3-12-02 study, completed the study and did not discontinue for lack of efficacy or safety
- •Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
- •Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
- •If female and of childbearing potential, is nonlactating and nonpregnant
排除标准
- •History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam
- •Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip
- •Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
- •Significant difficulties swallowing capsules or unable to tolerate oral medication
- •Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening
研究组 & 干预措施
Meloxicam Test Capsules
Experimental
One Capsule QD
干预措施: Meloxicam Test Capsules (Drug)
结局指标
主要结局
Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
时间窗: Baseline to Week 52/Early Termination
The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.
次要结局
未报告次要终点
研究者
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