A Randomized, Multicenter Study Comparing the Analgesic Efficacy and Safety of Hydrocodone / Acetaminophen Extended Release to Placebo in Subjects With Acute Pain Following Bunionectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
研究概览
简要总结
The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.
详细描述
The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol.
After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or 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
- 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
- •Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy
排除标准
- •Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures
- •Drug allergies to hydrocodone, acetaminophen
- •Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction
研究组 & 干预措施
Placebo
placebo, 1 oral tablet every 12 hours
干预措施: Placebo (Drug)
Hydrocodone/Acetaminophen Extended Release
hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours
干预措施: Hydrocodone/Acetaminophen Extended Release (Drug)
结局指标
主要结局
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
时间窗: From time of first study drug administration to 12 hours following first study drug administration
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
次要结局
- SPRID (Pain Relief and Pain Intensity Difference)(From time of first study drug administration to 12 hours following first study drug administration)
- TOTPAR (Total Pain Relief)(From time of first study drug administration to 12 hours following first study drug administration)
- Time to Perceptible and Meaningful Pain Relief(From time of first study drug administration to 12 hours following first study drug administration)