NCT00817986已完成2 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of XP19986 in Subjects With Acute Back Spasms
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil sustained release tablets taken every 12 hours compared to placebo in subjects with acute back spasms in the lumbar region.
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
- •Acute moderate to severe muscle spasms in the lumbar region, as indicated by a minimum Visual Analog Scale pain severity score of 4.0 cm, beginning either:
- •within four days prior to screening for subjects who do not require a 24-hour washout
- •within three days for subjects who require a 24-hour washout
- •Willing to discontinue all analgesics (e.g. NSAIDS, COX-2 inhibitors, acetaminophen), aspirin >81 mg/day, short-acting muscle relaxants (i.e. carisoprodol, Soma®), and herbal remedies for pain at least 24 hours prior to first dose and to refrain from use during the study (cardio-protective doses of aspirin ≤ 81 mg /day are allowed).
排除标准
- •Clinically significant abnormal neurological history or examination at screening (excluding back spasm), including lumbar radicular symptoms, spinal stenosis, foot drop, herniated nucleus pulposus, or other structural defects
- •Subjects with back spasm related to major trauma to the region
- •Subjects with muscle spasms due to a work-related injury or subjects involved in any injury-related litigation
- •Subjects using any of the following medications at screening:
- •Opioids, both short- and long-acting including but not limited to: morphine, fentanyl patch, oxycodone, tramadol)
- •benzodiazepines, such as valium and lorazepam
- •cyclobenzaprine containing drugs (e.g., Flexeril, Amrix)
- •carisoprodol (e.g., Soma®) within 24 hours of screening
研究组 & 干预措施
Arbaclofen placarbil 20 mg
Experimental
Arbaclofen placarbil 20 mg, BID, for 14 days including the taper period.
干预措施: Arbaclofen placarbil, 20 mg (Drug)
Placebo for Arbaclofen placarbil
Placebo Comparator
Placebo for 14 days
干预措施: Placebo (Drug)
Arbaclofen placarbil 30 mg
Experimental
Arbaclofen placarbil 30 mg, BID, for 14 days including the taper period.
干预措施: Arbaclofen placarbil, 30 mg (Drug)
Arbaclofen placarbil 40 mg
Experimental
Arbaclofen placarbil 40 mg, BID, for 14 days including the taper period.
干预措施: Arbaclofen placarbil, 40 mg (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: 14 Days
Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs
次要结局
- Change in pain severity score using the VAS(4 Days)
研究者
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