A Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy of ThermoProfen™ in the Treatment of Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee (ZMK-301)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 679
- 主要终点
- The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours.
研究概览
简要总结
ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.
详细描述
The primary objective of the study is to compare the efficacy of ThermoProfen™ against two other experimental treatments.
The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 through 75 years of age
- •Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year.
排除标准
- •Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs, including aspirin).
- •Patient has asthma that has been induced or made worse by the use of aspirin or NSAIDs.
- •Patient has a relevant history of serious gastrointestinal disease.
- •Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
- •Patient is taking warfarin, heparin, or low molecular weight heparin.
- •Patient has received oral, intramuscular, intravenous, intra-articular, or soft-tissue administration of steroids within 1 month of study enrollment (or within 2 months, if in the target joint).
- •Patient has received intra-articular visco-supplementation (in target joint) within 6 months of study enrollment.
研究组 & 干预措施
Thermoprofen
ThermoProfen™ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery [CHADD™] patch)
干预措施: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System) (Drug)
Placebo Matrix
Placebo matrix with CHADD patch.
干预措施: Placebo Matrix/CHADD Patch (Drug)
Ketoprofen matrix/placebo CHADD
Ketoprofen matrix with placebo CHADD patch (no heat)
干预措施: Ketoprofen matrix/placebo CHADD Patch (Drug)
结局指标
主要结局
The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours.
时间窗: 12 weeks
次要结局
- Change from baseline in Visual Analog Scale score for worst pain during the previous 24 hours, amount of rescue medication used to treat the target joint per day, and the patient global impression of change in the Likert Scale(12 weeks)