NCT00404391已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Hydrocodone/Acetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery
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
- Abbott
- 入组人数
- 210
- 试验地点
- 4
- 主要终点
- Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ages 18 to 65
- •Females must be of non-childbearing potential or practicing birth control
- •Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery
排除标准
- •Is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs
- •Has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study
- •Is associated with any currently ongoing research study
研究组 & 干预措施
Arm 1: hydrocodone/acetaminophen extended release
Experimental
干预措施: Hydrocodone/Acetaminophen Extended Release (Drug)
Arm 2: hydrocodone/acetaminophen extended release
Experimental
干预措施: Hydrocodone/Acetaminophen Extended Release (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration
时间窗: 12 hours
Pain relief measured by a 100mm Visual Analog Scale (VAS)
次要结局
- Time interval weighted sum of pain intensity difference (SPID)scores(12 hours)
研究者
研究点 (4)
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