Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 42
- 主要终点
- Mean Effect Size in Subjected-Rated Pain
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three times a day (TID) in approximately 400 male and female subjects experiencing back pain due to or associated with muscle spasm.
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
- •Ambulatory
- •Current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain.
- •Pain of 4 or more on the subject "right now" rating of pain intensity Numeric Rating Scale (NRS) scale of 0-
- •Willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry.
- •Pain localized below the neck and above the inferior gluteal folds.
- •Body mass index ranging between 18 and 35 kg/m².
排除标准
- •Unwillingness to stop taking pain or antispasmodic medication other than the study medication (specifically opioid use [e.g., Vicodin], barbiturates, and cannabis).
- •Chronic pain for the previous 3 months or longer, on more days than not.
- •Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy).
- •Concomitant severe pain in a region other than the back.
- •Spinal surgery within 1 year of study entry.
- •Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year.
- •Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation [TENS], physiotherapy).
- •Subjects who test positive for alcohol by breathalyzer test.
- •Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP) isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).
研究组 & 干预措施
Tolperisone 50 mg
TID (150 mg/day)
干预措施: Tolperisone (Drug)
Tolperisone 100 mg
TID (300 mg/day)
干预措施: Tolperisone (Drug)
Tolperisone 150 mg
TID (450 mg/day)
干预措施: Tolperisone (Drug)
Tolperisone 200 mg
TID (600 mg/day)
干预措施: Tolperisone (Drug)
Placebo
TID
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Effect Size in Subjected-Rated Pain
时间窗: Day 1 to Day 14
Mean effect size between Tolperisone and Placebo of subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain) on Day 14 "right now."
次要结局
未报告次要终点