An Open-Label, Long-Term Safety Study to Evaluate the Safety of ThermoProfen™ for the Treatment of Mild to Moderate Pain Associated With Osteoarthritis of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 179
- 试验地点
- 20
- 主要终点
- To evaluate the safety of long-term administration of ThermoProfen™
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 the safety of long-term administration of ThermoProfen™ for the pain associated with osteoarthritis of the knee in adults. The study will be conducted in patients with pain associated with osteoarthritis and who have completed a previous efficacy study of ThermoProfen.
详细描述
The objective of the study is to evaluate the safety of long-term administration of ThermoProfen for the pain associated with osteoarthritis of the knee in adults.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient completed a previous efficacy study of ThermoProfen.
排除标准
- •Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin).
- •Patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in ThermoProfen (such as that found in adhesive bandages, e.g. Band-Aid®).
- •Patient has asthma that has been induced or made worse by the use of aspirin or any other NSAID.
- •Patient has a relevant history of serious gastrointestinal disease.
- •Patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
- •Patient has neurological or psychiatric disease sufficient to compromise data collection or integrity.
- •Patient is taking warfarin, heparin, or low molecular weight heparin.
- •Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
结局指标
主要结局
To evaluate the safety of long-term administration of ThermoProfen™
时间窗: up to 12 months
次要结局
未报告次要终点