NCT04671082已完成3 期
A Phase 3, 14-Day, Double-blind, Randomized, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,004
- 试验地点
- 50
- 主要终点
- Numerical rating scale (NRS)
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, multicenter study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered in subjects with pain due to acute back 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory
- •Current acute back pain due to acute muscle spasm starting within 7 days prior to study entry (Day 1) and at least 8 weeks following resolution of the last episode of acute back pain.
- •Willingness to discontinue all previous or ongoing treatment of pain or muscle spasm on study entry at Day 1 through the end of treatment including medication, acupuncture, chiropractic adjustment, massage, transcutaneous electrical nerve stimulation [TENS], or physiotherapy.
- •Pain must be localized from the neck (C-3 or lower) to the inferior gluteal folds and spasm assessed during the Screening physical examination.
- •Body mass index range between 18 and 35 kg/m², inclusive.
排除标准
- •Presence of acute or chronic back pain for the previous 8 days or longer, where back pain is present on more days than not.
- •Presence of neurogenic pain in the back, neck, upper or lower extremities, including pain from (or suspected from) nerve root compression or injury (radicular pain or "pinched nerve") or neuropathic pain. Evidence of these types of exclusionary pain includes radiation of pain that radiates beyond the back, chronic pain, and pain associated with abnormal sensation or loss of sensation in the back or extremities.
- •Presence of pain anywhere other than the target back pain that is bothersome, interferes with activity, or for which pain relief is taken.
- •History of any neck, back, or pelvic surgery.
- •History within the previous 3 years of: spinal fracture or spinal infection; inflammatory arthritis; degenerative spine disease; or any other back or spine condition that may reasonably contribute to current back pain.
- •Subjects who test positive for alcohol by breathalyzer test or have a positive urine drug screen for drugs of abuse (e.g. amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, oxycodone, opiates), including cannabis even where legal, at Screening.
研究组 & 干预措施
Tolperisone 50 mg
Experimental
Tolperisone 50 mg
干预措施: Tolperisone Hydrochloride (Drug)
Tolpersione 100 mg
Experimental
Tolperisone 100 mg
干预措施: Tolperisone Hydrochloride (Drug)
Tolperisone 200 mg
Experimental
Tolperisone 200 mg
干预措施: Tolperisone Hydrochloride (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Numerical rating scale (NRS)
时间窗: Day 1 to Day 14
Numerical rating scale (NRS), a 0-10 scale, from no pain to worst possible pain - Subject-rated pain "right now" due to acute back spasm.
次要结局
未报告次要终点
研究者
研究点 (50)
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