A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of Hydrocodone/Acetaminophen Extended Release Compared to Placebo in Subjects With Chronic Low Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 17
- 主要终点
- Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
研究概览
简要总结
The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.
详细描述
This phase 2, multicenter, double-blind (DB), placebo-controlled, randomized withdrawal study compared the analgesic efficacy and safety of hydrocodone/acetaminophen extended release to placebo in subjects with moderate to moderately severe chronic lower back pain (CLBP). Participants met pre-defined criteria at the conclusion of the open-label (OL) Titration Period to proceed to randomization into the double-blind (DB) Maintenance Period of the study. Study drug was given for a total of approximately 5 weeks, which included 2 weeks in OL, 2 weeks in DB, and a 3-day taper. During the OL period, all participants took increasing doses of hydrocodone/acetaminophen extended release until they were taking 2 tablets, twice daily. During the DB period, participants in the hydrocodone/acetaminophen extended release group took 1 hydrocodone/acetaminophen extended release tablet twice daily throughout the 2 weeks, while participants in the placebo group took 1 placebo tablet twice daily.
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
- •Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration
排除标准
- •Subjects with a history of surgical or invasive intervention
研究组 & 干预措施
Open-label Hydrocodone/Acetaminophen Extended Release
Hydrocodone/acetaminophen extended release, 2 tablets twice daily
干预措施: hydrocodone/acetaminophen extended release (Drug)
Double-blind Hydrocodone/Acetaminophen Extended Release
Hydrocodone/acetaminophen extended release, 1 tablet twice daily
干预措施: hydrocodone/acetaminophen extended release (Drug)
Double-blind Placebo
Placebo, 1 tablet twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
时间窗: Double-blind baseline to Day 29
The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model.
次要结局
- Participant's Global Assessment of Back Pain Status at Final Evaluation(Double-blind baseline to Day 29)
- Participant's Global Assessment of Study Drug at Final Evaluation(Double-blind baseline to Day 29)