NCT01015235已完成2 期
A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion for the Treatment of Postoperative Pain
KAI Pharmaceuticals0 个研究点目标入组 90 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).
研究概览
简要总结
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.
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
- Double (Participant, Investigator)
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
- •American Society of Anesthesiologist (ASA) classification 1, 2, or 3
- •total hip or total knee replacement
- •pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS)
排除标准
- •presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment
- •recent history of angina or myocardial infarction (MI)
- •clinically significant abnormality on laboratory tests or electrocardiogram (ECG)
研究组 & 干预措施
A2: KAI-1678
Active Comparator
Test Drug
干预措施: KAI-1678 (Drug)
Arm 1: Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
A3: Ketorolac
Active Comparator
Active Comparator
干预措施: Ketorolac Tromethamine (Drug)
结局指标
主要结局
The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).
时间窗: Post operative Day 1
次要结局
- The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)(Post operative Day 1)
- The effect of KAI-1678 on pain intensity difference (PID) at 4 hours(Post-operative Day 1)
- The effect of KAI-1678 on total quality analgesia(Post-operative Day 1)
- The effect of KAI-1678 on time to meaningful pain relief(Post-operative Day 1)
研究者
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