Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 43
- 主要终点
- Change of Numeric Pain Scale
研究概览
简要总结
The goal of this clinical trial is to learn if a modification to metaxalone 640 mg can reduce low back and leg pain. The participants will be 18 to 80 years old, healthy with newly occurring back or leg pain. The main question aims to compare a group taking active treatment and a group taking a look-alike substance containing no active treatment. All participants will answer questions on Day 1, before treatment, and on 7-day after treatment, about:
- Amount and quality of pain
- Interference with physical activity
- Interference with sleep
详细描述
Double-blind, randomized, placebo-controlled, multi-center study of metaxalone 640 mg plus standard of care for patients with acute lumbo sacral musculoskeletal conditions with spinal stenosis and sciatica. Participants will be randomized 1:1. Following the initial pilot-study a second study will randomize a larger population of patients with appropriate power.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant conditions impacting quality or quantity of pain
- •Baseline Numeric Pain Scale ≥ 6
- •Capable of answering text or email survey reminders
- •Low back pain with or without sciatica
排除标准
- •Current use of other skeletal relaxants
- •Current use of other pain relievers
- •Current use of cimetidine or monoamine oxidase inhibitors
研究组 & 干预措施
Active M640
Metaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days
干预措施: Metaxalone 640 mg Oral Tablet (Drug)
Placebo
Inactive placebo capsule 640 mg Taken orally every 6 hours for 7 days
干预措施: Metaxalone 640 mg Oral Tablet (Drug)
结局指标
主要结局
Change of Numeric Pain Scale
时间窗: Day 1 to Day 7
Change from Baseline in low back pain and leg pain as measured by the Numeric Pain Rating Scale (NPRS) at Day 7
次要结局
未报告次要终点