A Phase 3, Open-Label Period Followed by a Randomized, Double-blind Placebo-controlled Study of the Analgesic Efficacy of Extended-release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects With Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 287
- 试验地点
- 31
- 主要终点
- Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
研究概览
简要总结
The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).
详细描述
The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female subjects who voluntarily sign the informed consent
- •Diagnosis of CLBP of 6 months duration
排除标准
- •Incapacitated or bedridden subjects
- •Subjects with history of surgical or invasive intervention
研究组 & 干预措施
Open-label ABT-712
2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
干预措施: ABT-712 (Drug)
Double-blind ABT-712
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
干预措施: ABT-712 (Drug)
Double-blind Placebo
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
时间窗: Double-blind baseline to 4 weeks
The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB 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 2-way ANCOVA model without interaction.
次要结局
- Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)(Double-blind baseline to 4 weeks)