NCT00553592Unknown2 期
A Double-Blind, Randomized, Placebo-Controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Pain and Safety
研究概览
简要总结
To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic periperal neuropathy in adult outpatients.
To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male or female, 18 years or older
- •Diagnosis of type-1 or type 2 non-insulin dependent diabetes mellitus
- •Chronic bilateral pain due to diabetic neuropathy
- •Pain for at least six months
- •Primary pain is located in the feet
- •Others-contact site for information
排除标准
- •Symptoms of other painful conditions
- •Presence of amputations other than toes
- •Clinically significant psychiatric or other neurological disorder
- •Use of certain medications
- •Clinically important other diseases
- •Pregnancy
- •History of alcohol or narcotic abuse within two years
- •Others-contact site for information
研究组 & 干预措施
Drug
Experimental
Bicifadine
干预措施: Bicifadine (Drug)
Drug: 2
Experimental
Bicifadine
干预措施: Bicifadine (Drug)
Control
Placebo Comparator
Placebo of Bicifadine
干预措施: Bicifadine (Drug)
结局指标
主要结局
Pain and Safety
时间窗: 14 weeks
次要结局
- Clinical Global Impression of Improvement, McGill Pain Questionnaire, Amount of Rescue Medication Used for Pain, Quality of Life Survey (SF-36), Patient Global Impression of Change(14 weeks)
研究者
研究点 (1)
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