NCT00404222已完成2 期
A Randomized, Multicenter, Single-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) to Placebo in Subjects With Acute Pain Following Bunionectomy
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
- 90
- 主要终点
- The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following 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 Extended Release Hydrocodone/Acetaminophen and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, 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
- Single
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
- •Males and females ages 18 to 65
- •Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
- •Must meet specific pain intensity criteria on the morning after surgery
- •Willing to remain at the study center 2 days following surgery
- •If female, must be of non-child bearing potential or practicing birth control
排除标准
- •Is allergic to or has a serious reaction to hydrocodone, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
- •Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
- •Has a history of or currently has any active seizure disorder
- •Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract
- •Has been diagnosed with cancer within the past 3 years
- •Requires treatment with certain drugs for depression or psychiatric disorders
- •Has specific clinically significant illnesses or laboratory abnormalities
- •Received corticosteroid treatment or any investigational drug within a specific timeframe.
研究组 & 干预措施
hydrocodone / acetaminophen extended release
Experimental
干预措施: Hydrocodone/Acetaminophen Extended-Release (Drug)
Hydrocodone/Acetaminophen Immediate Release (Norco ®)
Active Comparator
干预措施: Hydrocodone/Acetaminophen Immediate Release (NORCO®) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration.
时间窗: 12 hours
Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS)
时间窗: 12 hours
次要结局
- Time to first noticeable pain relief (i.e., onset of pain relief)(12 hours)
- Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)(12 hours)
- Proportion of subjects experiencing meaningful pain relief after dosing(12 hours)
- Time-interval weighted sum of pain relief (TOTPAR)(12 hours)
- Time-interval weighted sum of pain relief and pain intensity difference (SPRID)(12 hours)
研究者
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