A Multicenter Standard of Care-Controlled Study to Evaluate the Long-Term Safety of Bicifadine for the Treatment of Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,250
- 主要终点
- Adverse Events
研究概览
简要总结
The primary objective of the study is to evaluate the safety and efficacy of bicifadine 400 mg BID for up to one year in patients with moderate to severe chronic low back pain.
The secondary objectives are to compare the long-term safety of bicifadine to standard of care therapy, to evaluate the safety of bicifadine following discontinuation of dosing, and to evaluate the safety and efficacy of lower doses of bicifadine in patients who do not tolerate bicifadine 400 mg BID.
详细描述
There are two ways by which subjects could enter this study.
Subjects who completed 12 weeks of treatment in two other double blind clinical studies of bicifadine (Studies 020 and 021, both in the United States) could roll over into this study.
Also, de novo subjects (that is, subjects who had not previously received bicifadine) could enroll in this study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（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 over the past 3 months prior to screening.
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) or weakness in the lower extremities.
- •Patients must not have had epidural corticosteroid injections in the lower back within 1 month prior to baseline.
- •Patients may not have an unstable medical condition.
结局指标
主要结局
Adverse Events
Clinical Labs
Vital Signs
ECGs
次要结局
- Pain Severity Rating (VAS)
- Short-Form McGill Pain Questionnaire (SF-MPQ)
- Roland-Morris Disability Questionnaire (RDQ)
- Short-Form 36 (SF-36) Health Survey
- Patient Withdrawal Checklist