NCT00034710已完成2 期
A Double-Blind Controlled Pilot Study of High-Dose Capsaicin Patches in the Treatment of Pain Associated With Postherpetic Neuralgia
NeurogesX8 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2002年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 8
研究概览
简要总结
The purpose of this study is to gain initial information on the tolerability of high-dose capsaicin patches in patients with Painful Postherpetic Neuralgia. The study will also collect preliminary information on safety and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- •Eligibility Criteria
- •Inclusion Criteria:
- •Patients may be eligible for this study if they:
- •Have a diagnosis of Painful Postherpetic Neuralgia and are at least 6 months post vesicle crusting.
- •Are in good health.
- •Have an adequate pain score during the screening period.
- •Have painful areas (maximum of two sites) below the neck.
- •If female, are of non-childbearing ability as defined by absence of menses for a minimum of 3 months or surgically sterile.
- •If male, are willing to agree to take adequate birth control precautions with their partner for 60 days following experimental drug exposure.
- •Have unbroken skin with good perfusion over the painful area(s).
- •Have the ability to feel capsaicin-mediated sensations, as evidenced by ability to feel topically applied OTC capsaicin cream.
- •Are on a stable and continuous medication regimen, with no change in dosage for 21 days prior to study start, and are willing to maintain concomitant medications at current doses throughout the study.
- •Are willing and able to use oral opioid-based analgesic agents for relief, in case this is needed to relieve acute pain associated with the application of capsaicin patches.
- •Are 18 years of age or older.
- •Are willing and able to comply with the protocol
排除标准
- •Patients will not be eligible for this study if they:
- •Have diffusely distributed neuropathic pain (i.e., pain that is evident in more than 2 different sites). Subjects must not have significant pain outside the areas to be treated.
- •Have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
- •Currently (within the past 21 days) use topically applied non-steroidal anti-inflammatory drugs, local anesthetics, steroids or capsaicin products on the painful areas.
- •Currently (within the past 21 days) use topical agents such as lidoderm patch 5%, topical steroids or aspirin.
- •Have a history or current problem with prescription drug or illicit substance abuse (from self report or as judged by investigator).
- •Currently have an abuse problem with alcohol (from self-report or as judged by investigator).
- •Are suspected of psychosocial gain/benefit of continued pain as judged by the investigator or primary treating physician.
- •Plan to travel more than 100 miles from home during the study or engage in unusual activities that might exacerbate pain.
- •Have poor cardiac, renal, hepatic, or pulmonary function judged by the investigator or primary treating physician.
- •Have a laboratory value at screening outside the normal range, unless it is judged by the investigator as not clinically significant after appropriate evaluation.
- •Have hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, oral opioid-based analgesic agents, or adhesives.
- •Have a high tolerance to opioids.
- •Currently using Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).
研究者
研究点 (8)
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