A Phase 3 Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- The safety of CL-108 will be evaluated and assessed by questionnaire, when used, for the treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip.
研究概览
简要总结
The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use.
详细描述
The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use.
The study will also endeavor to determine
- the physicians' global evaluation of CL-108 as a treatment for moderate to severe acute pain associated with osteoarthritis of the knee or hip
- the patients' global impression of change in pain after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip
- any change in the patient's quality of life after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip
- the percentage change in pain intensity after treatment of moderate to severe acute pain associated with osteoarthritis 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CL-108
CL-108 Hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg
干预措施: CL-108 (Drug)
结局指标
主要结局
The safety of CL-108 will be evaluated and assessed by questionnaire, when used, for the treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip.
时间窗: 24 hours
次要结局
- The change in arthritic pain since taking study medication over a specific period will be assessed on the Patient Global Impression of Change scale (PGIC)(24 hours)
- Patients will complete a standard QOL questionnaire, comprising five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression).(24 hours)
- An assessment of the study medication will be provided as a treatment for osteoarthritis on the Physician's Global Evaluation (PGE) utilizing a poor to excellent scale(24 hours)
研究者
Joseph Hazelton
Vice President, Regulatory Affairs
Charleston Laboratories, Inc