NCT00478179已完成2 期
A Randomized, Double-Blind, Placebo Controlled, Two-Way Cross-Over Study of Analgesic Efficacy of Bupivacaine Transdermal Therapeutic System in Patients With Post-Herpetic Neuralgia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Durect
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Reduction of pain with mean daily pain intensity
研究概览
简要总结
Neuropathic pain is caused by a virus commonly associated with chicken pox. This virus may become dormant in the nervous system and later reactivate causing herpes zoster, also known as "shingles". Post-herpetic neuralgia (PHN) is a persistent pain in the area of healed skin lesions. This study will test the safety and efficacy of treating PHN patients with the analgesic patch, Bupivacaine TTS (Eladur™).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females age 21 years or older.
- •Pain in thoracic or lumbar regions for a minimum of 90 days after crusting of Herpes Zoster (HZ) lesions.
- •Stable prescribed medications regimen (including opioids, anticonvulsants, and tricyclic antidepressants).
- •Intact, unbroken skin over the painful area to be treated.
- •Body Mass Index (BMI) no more than 35 kg/m2.
排除标准
- •Active HZ lesions, dermatitis, Central Nervous System (CNS) injury.
- •Any immunosuppressed condition, including but not limited to AIDS/HIV and Hodgkin's lymphoma.
- •Pain control by nerve block or neurosurgical intervention.
- •Evidence of clinically significant hepatic, gastrointestinal, renal, hematologic, urologic, neurologic, respiratory, endocrine or cardiovascular system abnormalities, psychiatric disorders, or acute infection.
- •Connective tissue disorders (systemic lupus erythematosus, scleroderma, mixed connective tissue disease).
- •Recent use (within 30 days preceding the first treatment visit) of any topically applied pain medication, such as nonsteroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas.
- •Significant pain of an etiology other than PHN, for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis. Patients must not have significant ongoing pain from other cause(s) that may interfere with judging PHN related pain.
- •Participation in a clinical trial of an investigational product or device within 30 days of the screening visit or concurrently during the conduct of this study.
结局指标
主要结局
Reduction of pain with mean daily pain intensity
次要结局
- Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.
研究者
研究点 (7)
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