NCT00295711已完成3 期
A Multi-Center Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 Mg BID, Bicifadine 300 Mg BID, and Bicifadine 400 Mg BID in the Treatment of Chronic Low Back Pain
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 532
- 主要终点
- - Pain Severity Rating (100 mm visual analog scale)
研究概览
简要总结
The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine at three oral dose levels compared with placebo in patients with moderate to severe chronic low back pain.
The secondary objectives are to investigate the dose-response relationship of three dose levels of bicifadine, to evaluate the clinical meaningfulness of bicifadine efficacy, to evaluate the effect of bicifadine on function and general quality of life, to describe the population pharmacokinetics of bicifadine in patients with chronic low back pain, and to evaluate safety following discontinuation of bicifadine treatment.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with low back pain assessed as Class 1, Class 2 or Class 3 according to the Quebec Task Force Classification for Spinal Disorders and without detectable leg weakness on neurological examination.
- •Patients must have required on average daily analgesics for the treatment of low back pain for at least 3 months prior to dosing.
排除标准
- •Patients may not have moderate or severe pain in a location other than the lower back (with the exception of radiation to the lower extremity).
- •Patients must not have had lower back surgery within 6 months prior to baseline, nor epidural corticosteroid injections within 3 months prior to baseline.
- •Patients may not have an unstable medical condition.
结局指标
主要结局
- Pain Severity Rating (100 mm visual analog scale)
次要结局
- Short-Form McGill Pain Questionnaire (SF-MPQ)
- Roland-Morris Disability Questionnaire (RDQ)
- Short-Form 36 (SF-36) Health Survey
- Patient's Global Impression of Change (7-point categorical scale)Physician's Global Impression of Change (7-point categorical scale)
- Patient's Global Evaluation of Study Medication (5-point categorical scale)
- Physician's Global Evaluation of Study Medication (5-point categorical scale)
- Incidence of study discontinuation due to lack of efficacy
- Plasma PK of bicifadine
研究者
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