NCT00680472已完成3 期
Protocol HKT-500-US08: A Randomized, Multicenter, Double-blind, Placebo-controlled, Two-week Study to Assess the Efficacy and Safety of HKT-500 in Subjects With Acute Shoulder Pain
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
- 368
- 试验地点
- 3
- 主要终点
- Pain Assessment
研究概览
简要总结
The objective of this study is to determine the efficacy of HKT-500 in subjects with acute shoulder pain
详细描述
Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or greater who have acute shoulder pain requiring analgesic treatment daily for at least 2 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •The subject has unilateral acute shoulder pain.
排除标准
- •The subject is a women of childbearing potential who has a positive urine pregnancy test, or who is lactating, or who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.
研究组 & 干预措施
A,1 HKT-500 Ketoprofen Topical Patch
Active Comparator
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects with Acute Shoulder Pain
干预措施: HKT-500 Ketoprofen Topical Patch (Drug)
A,2 Placebo Patch
Placebo Comparator
Treatment with placebo patch
干预措施: Placebo Patch (Other)
结局指标
主要结局
Pain Assessment
时间窗: 2 Weeks
次要结局
- Safety Assessment(2 weeks)
研究者
研究点 (3)
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