NCT01250561已完成不适用
Reduction of Postherpetic Neuralgia in Herpes Zoster
Center for Clinical Studies, Texas2 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2002年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Proportion of patients with zoster pain at 6 months
研究概览
简要总结
The addition of gabapentin therapy to standard antiviral treatment with valacyclovir in acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients of 50 years of age and older.
- •Patients with a clinical diagnosis of uncomplicated herpes zoster presenting within the first 72 hours of vesicles.
- •Patients who are willing and able to comply with the requirements of the study.
- •Patients who are willing and able to give written informed consent.
- •Average pain score pre-therapy greater or equal than 4 on 10-point Likert scale.
排除标准
- •Sexually-active women of childbearing potential, including postmenopausal women less than 1 year since last menses, not employing adequate contraception (approved oral contraceptive, intrauterine device, barrier methods or total abstinence).
- •Pregnant females and nursing mothers.
- •Patients with immune dysfunction including congenital immune deficiency, active malignancy of any type, collagen vascular diseases, organ or bone marrow transplantations, known infection with HIV or severe atopic dermatitis.
- •Patients who have received cytotoxic drugs or immunosuppressive therapy (e.g., chronic systemic corticosteroids) within the previous 3 months.
- •Patients with evidence of cutaneous or visceral dissemination of herpes zoster infection (cutaneous dissemination is defined as > 20 discrete lesions outside adjacent dermatomes).
- •Patients who have received systemic anti-VZV medications or immunomodulatory medications (including interferon) within the previous 4 weeks.
- •Patients currently receiving probenecid.
- •Patients with impaired renal function: calculated creatinine clearance of <30 mL/min using Cockcroft and Gault formula.
- •Patients with abnormal liver function (alanine transaminase (ALT) or aspartate;transaminase (AST) levels greater than five times the upper limit of the normal range).
- •Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, famciclovir or gabapentin.
- •Patients currently receiving therapy with gabapentin or tricyclic antidepressants.
- •Patients with clinical evidence of ocular involvement of herpes zoster. Patients with herpes zoster of the ophthalmic branch of the trigeminal nerve without evidence of ocular involvement will be included.
结局指标
主要结局
Proportion of patients with zoster pain at 6 months
次要结局
- Proportion of patients with zoster pain at 4 months
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
1 期
The Efficacy of Botulinum Toxin, Triamcinolone or Fu's needle for the Treatment of refractory Post-Herpetic Neuralgiapostherpetic neuralgiaITMCTR2200005993Xiao Bao
已完成
早期 1 期
3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia (PHN)Treatment of PHNNCT03421613CDA Research Group, Inc.28
已完成
不适用
Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in FranceHerpes ZosterNCT02487472GlaxoSmithKline106
Unknown
3 期
Pregabalin Treatment and Prevention Post-herpetic NeuralgiaHerpetic NeuralgiaNCT03186443Second Affiliated Hospital of Guangzhou Medical University342
已完成
不适用
Rhomboid Intercostal and Subserratus Plane Block Versus Paravertebral Block for Thoracic Herpes ZosterThoracic Herpes ZosterNCT06751680Xiaguang Duan30