NCT01722864已完成3 期
An Open Label Safety Study of COV155 in Subjects With Osteoarthritis or Chronic Low Back 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
- 发起方
- Mallinckrodt
- 入组人数
- 153
- 试验地点
- 34
- 主要终点
- Safety and tolerability of COV155
研究概览
简要总结
A study to show the safety of COV155 in patients with osteoarthritis of the knee or hip or moderate to severe chronic low back pain.
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
COV155
Experimental
COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 10 to 35 days.
干预措施: COV155 (Drug)
结局指标
主要结局
Safety and tolerability of COV155
时间窗: Up to 35 days
Safety evaluations using physical exam, vital signs, clinical laboratory tests, pulse oximetry, and adverse events.
次要结局
- Modified Brief Pain Inventory short form (mBPI-sf) - pain interference(Baseline, Weeks 1, 2, 3, 4, and 5)
- Modified Brief Pain Inventory short form (mBPI-sf) - pain relief(Baseline, Weeks 1, 2, 3, 4, and 5)
- Roland Morris/Disability Questionnaire(Baseline, Weeks 1, 2, 3, 4, and 5)
- Modified Brief Pain Inventory short form (mBPI-sf) - intensity(Baseline, Weeks 1, 2, 3, 4, and 5)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Baseline, Weeks 1, 2, 3, 4, and 5)
研究者
研究点 (34)
Loading locations...
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