An Open Label Safety Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 376
- 试验地点
- 41
- 主要终点
- Summary of Adverse Events (AEs)
研究概览
简要总结
The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35 days use as evaluated by physical exam, vital signs, pulse oximetry, clinical laboratory tests, and other adverse events (AEs).
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
COV795
Participants receive 2 tablets of COV795 every 12 hours for up to 35 days
干预措施: COV795 (Drug)
结局指标
主要结局
Summary of Adverse Events (AEs)
时间窗: 5 Weeks
Collection of AEs began with subject's signing of the informed consent form, continued throughout the trial, and ended 7 days following the last dose of study drug, or at early termination. Treatment emergent AEs (TEAEs) are AEs that occurred after the first dose of study drug. TEAEs leading to discontinuation include 2 subjects who died (deaths not related to study drug). Clinically significant changes in values from physical exam, vital signs, clinical laboratory tests, and pulse oximetry were included as treatment emergent adverse events (TEAEs).
次要结局
- Modified Brief Pain Index - Short Form: Percent Pain Relief From Medication(at end of treatment (within 5 weeks))
- WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Physical Function Score(End of treatment (within 5 weeks))
- Roland-Morris Low Back Pain and Disability Scores for Participants With Chronic Low Back Pain(End of treatment (within 5 weeks))
- Modified Brief Pain Inventory-Short Form: Pain Interference Scores(at end of treatment (within 5 weeks))
- WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Stiffness Score(End of treatment (within 5 weeks))
- Modified Brief Pain Index - Short Form: Pain Intensity(at end of treatment (within 5 weeks))
- WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Total Score(End of treatment (within 5 weeks))
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Pain Score(End of treatment (within 5 weeks))