The Analgesic Efficacy and Safety of Topical Patches (Loxoprofen Sodium Patch) in Patients With Herpes Zoster
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days.
研究概览
简要总结
Herpes zoster (HZ) is characterized by a painful dermatomal rash and significantly affects quality of life, with acute pain increasing the risk of postherpetic neuralgia. Although early antiviral therapy limits viral replication, its analgesic effect is insufficient, and many patients experience inadequate relief despite stepwise use of non-opioids and opioids. Topical NSAIDs offer a promising alternative by delivering localized analgesia with reduced systemic exposure. Therefore, investigators hypothesize that loxoprofen sodium patch may effectively reduce the severity of HZ pain without significantly increasing adverse events.
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
- None
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
- •1. Ages more than 18 years;
- •2. Patients with onset of HZ rash less than 90 days;
- •3. Experiencing moderate to severe HZ pain with an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10 = worst possible pain);
- •4. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
- •5. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
- •6. Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.
排除标准
- •1. History of taking loxoprofen sodium patch;
- •2. Patients with evidence of cutaneous or visceral dissemination of HZ infection (cutaneous dissemination is defined as more than 20 discrete lesions outside adjacent dermatomes) or ocular involvement of HZ;
- •3. History of intolerance or hypersensitivity to any active components or excipient of the loxoprofen sodium patch;
- •4. History of systemic immune diseases, organ transplantation, or cancers;
- •5. Pregnancy or breastfeeding.
研究组 & 干预措施
Conventional therapy group
干预措施: Conventional therapy group (Drug)
Loxoprofen sodium patch combined with conventional therapy group
干预措施: Loxoprofen sodium patch combined with conventional therapy group (Drug)
结局指标
主要结局
the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days.
时间窗: At week 4 after experimental drug medication
The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.
次要结局
- The worst numeric rating scale score(at weeks 1, 2, 4, 8, and 12 after experimental drug medication)
- Proportion of Patients Achieving Pain Reduction(at weeks 1, 2, 4, 8, and 12 after experimental drug medication)
- Proportion of patients developing postherpetic neuralgia(at week 12 after experimental drug medication)
- The type of analgesics and average weekly consumption per analgesics(at weeks 4, 8, and 12 after experimental drug medication)
- The 12-item Short-Form Health Survey (SF-12) score(at weeks 4, 8, and 12 after experimental drug medication)
- The Medical Outcomes Study Sleep Scale (MOS)(at weeks 4, 8, and 12 after experimental drug medication)
- Adverse events(Through study completion, an average of 12 weeks)
研究者
Fang Luo
Director, Department of Pain Management, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital