NCT00597649终止2 期
An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral 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
- 状态
- 终止
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Pain and safety
研究概览
简要总结
This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.
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 90 Years（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.
- •Subject participated in and completed the XTL 07-001 clinical trial.
- •Contact site for additional information.
排除标准
- •Symptoms of other painful conditions
- •Presence of amputations other than toes
- •Clinically significant psychiatric or other neuropsychological disorder
- •Use of certain medications
- •Clinically important other diseases
- •Pregnancy
- •History of alcohol or narcotic abuse within two years.
- •Contact site for additional information.
研究组 & 干预措施
1
Experimental
Bicifadine 800 mg/day for a year
干预措施: Bicifadine (Drug)
2
Experimental
Bicifadine 1200 mg/day for a year
干预措施: Bicifadine (Drug)
结局指标
主要结局
Pain and safety
时间窗: one year
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(One year)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With DiabetesDiabetic Peripheral NeuropathyNCT00553592XTL Biopharmaceuticals336
已完成
3 期
Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back PainChronic Low Back PainNCT00281645DOV Pharmaceutical, Inc.1,250
已完成
3 期
A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity DisorderAttention Deficit DisorderAttention Deficit Hyperactivity DisorderNCT03605849Otsuka Pharmaceutical Development & Commercialization, Inc.662
已完成
3 期
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I DisorderBipolar I DisorderNCT00238485Novartis251
已完成
3 期
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.Bipolar I DisorderNCT00228059Novartis132