Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Preventive efficacy of Postherpetic neuralgia
研究概览
简要总结
In this study, the investigators aim to investigate the preventive efficacy of prophylactic oral duloxetine during acute herpes zoster on postherpetic neuralgia and its safety.
详细描述
Postherpetic neuralgia is a common complication of herpes zoster. Several interventions have been investigated for the treatment of postherpetic neuralgia, however, there is a lack of preventive intervention on postherpetic neuralgia. A recent retrospective study revealed that the administration of gabapentin during the acute herpes zoster period significantly decreased the incidence of postherpetic neuralgia. In the present study, the investigators aim to conduct a prospective, randomized, open-label, endpoint blinded study to investigate the preventive efficacy of prophylactic use of duloxetine on postherpetic neuralgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome of the study will be assessed by a third-party organization who will be blinded to the study allocation.
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
- •ages more than 50 years;
- •diagnosed with uncomplicated acute herpes zoster;
- •presents with vesicles within 72 hours;
- •has an average pain score of at least 40/100 mm on a visual analog scale (VAS, 0 = no pain, 100 = worst possible pain, at opposite ends of a 100-mm line).
排除标准
- •refuses to participate or to provide written informed consent;
- •Zung Self-Rating Depression Scale raw score of more than 50 points;
- •herpes zoster that involves with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system;
- •has hemorrhagic or necrotizing lesions, satellite lesions, abnormal vesicles or acute retinal necrosis;
- •has been on immunosuppressive therapy or mono- or multi-pharmacotherapy that involves any tricyclic antidepressant, valacyclovir, duloxetine or cytotoxic medications before acute HZ onset;
- •has been diagnosed with hepatic, renal or immune dysfunction;
- •during pregnancy or breastfeeding at the time;
- •hypersensitivity to the study drugs;
- •has contraindications to valacyclovir or duloxetine;
- •HZ vaccinated.
研究组 & 干预措施
Duloxetine
Apart from the standard treatment, participants in the Duloxetine Arm will be administered with oral duloxetine (up to 60 mg per day) in the acute herpes zoster period.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Preventive efficacy of Postherpetic neuralgia
时间窗: 12 weeks after the reactivation of acute herpes zoster
The proportion of participants in the Interventional Arm who gain a 0 score in a 100 mm visual analgue scale (0 mm = no pain, 100 mm = the most imaginable pain)
次要结局
- Averaged weekly VAS score(up to 12 weeks)
- Averaged weekly analgesic consumption(up to 12 weeks)
- Patients' overall quality of life(At the end of Weeks 4, 8, and 12)
- Sleep quality(At the end of Weeks 4, 8, and 12)
研究者
Fang Luo
Professor
Beijing Tiantan Hospital