NCT02074267已完成4 期
Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of pain intensity using the visual analog scale (VAS)
研究概览
简要总结
The purpose of this study is to assess the efficacy of Gabapentin (Carbatin & Neurontin) in patients with neuropathy pain.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have been diagnosed the disease of neuropathy pain arising from diabetic peripheral neuropathy, postherpetic neuralgia, traumatic/surgical nerve injury, incomplete spinal cord injury, or trigeminal neuralgia and if they have a mean weekly pain score of at least 4 on the 100-mm visual analog scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) completed a screening / baseline period before randomization. Additional disease-specific inclusion criteria are listed in Table
- •Subjects must be 20 years of age or older.
排除标准
- •Subjects who are pregnant, lactating or of childbearing potential not using effective contraceptives.
- •Subjects who have a clinically significant or unstable medical or psychiatric condition.
- •Subjects who are known of hypersensitivity to Gabapentin.
- •Serum creatinine > 1.5 times the upper limit of normal
- •Subjects who have received nerve blocks or acupuncture for pain relief within four weeks before a screening / baseline period.
- •Subjects who have the presence of chronic pain other than the target pain being studied (unless the chronic pain is in a different body region than the target pain and its intensity is not greater than that of the target pain).
- •Subjects who have received nondrug therapies or any special procedures for the relief of the target pain within two weeks before a baseline visit.
- •Subjects who are using the following agents within 30 days prior to screening: antidepressants, opioids, other anticonvulsants, local anaesthetic injections or any investigational drug.
研究组 & 干预措施
Carbatin
Experimental
Carbatin is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days
干预措施: Carbatin (Drug)
Neurontin
Active Comparator
Neurontin is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days
干预措施: Neurontin (Drug)
结局指标
主要结局
Evaluation of pain intensity using the visual analog scale (VAS)
时间窗: up to six weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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