NCT01510912已完成3 期
A Multicenter, Open-Label, Safety Study of Diclofenac [Test] 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
- 602
- 试验地点
- 36
- 主要终点
- Safety of Diclofenac 35 mg Capsules 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 Diclofenac [Test] Capsules for the treatment of osteoarthritis pain 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
- •Male or female ≥ [greater than or equal to] 40 years of age
- •If a participant in the previous DIC3-08-05 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
- •Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ [greater than or equal to] 20 days of the last 30 days before screening
排除标准
- •Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac
- •Requires chronic use of opioid or opioid combination products to control OA pain of the knee or hip
- •Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
- •Has significant difficulties swallowing capsules or is unable to tolerate oral medication
研究组 & 干预措施
Diclofenac Capsules 35 mg bid or tid
Experimental
干预措施: Diclofenac (Drug)
结局指标
主要结局
Safety of Diclofenac 35 mg Capsules 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 Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.
次要结局
未报告次要终点
研究者
研究点 (36)
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