NCT03246971已完成2 期
A Phase 2, Multiple-Dose Study of The Efficacy and Safety of Wafermine™ (Sublingual Ketamine) in Participants Experiencing Acute Post-Operative Bunionectomy or Abdominoplasty Pain
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale
研究概览
简要总结
This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of 4 subjects will receive placebo.
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
- 是
入选标准
- •Scheduled for a bunionectomy or mini abdominoplasty with no additional planned procedures.
- •Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.
排除标准
- •For those undergoing bunionectomy, other painful conditions involving the surgical foot.
- •Positive lab values for Hepatitis B or C or HIV
研究组 & 干预措施
Wafermine™
Experimental
干预措施: Wafermine™ 50 mg (Drug)
Wafermine™
Experimental
干预措施: Wafermine™ 75 mg (Drug)
Wafermine™
Experimental
干预措施: Wafermine™ 25 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebos (Drug)
结局指标
主要结局
Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale
时间窗: 12 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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