A Double-blind, Multicentre, Multiple-dose, Enriched Enrolment, Randomized-withdrawal, Parallel-group Phase III Study With Lido-Patch and Corresponding Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 265
- 主要终点
- Time-to-exit in Double-blind Phase Due to Lack of Efficacy
研究概览
简要总结
This study investigated the efficacy of the Lido-Patch (lidocaine 5% medicated plaster) in treatment of pain caused by PHN which is a neuropathic pain syndrome (nerve-related pain conditions) following an acute attack of herpes zoster (shingles).
详细描述
Participants were treated up to 10 weeks in this study: an 8-week Run-in Phase of open-label treatment with Lido-Patch was followed by a 2-day to 14-day Double-blind Phase with Lido-Patch or Placebo Patch treatment. Only participants responding to open-label treatment with Lido-Patch were included in the Double-blind Phase. In a Follow-up Phase without treatment, the safety of participants was monitored for 1-2 weeks. Alternatively, patch application could be continued for up to 12 months in the clinical study KF10004/02.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Open-label enriched enrolment followed by double-blind treatment for 2 weeks.
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
- 未提供
排除标准
- •Participation in another study of investigational drugs or devices parallel to, or less than 30 days before screening, or previous participation in this study.
- •Known to or suspected of not being able to comply with the study protocol.
- •Any clinically significant condition that would, in the investigator's opinion, preclude study participation for instance alcohol, medication or drug dependency, neurotic personality, psychiatric illness, epilepsy or suicide risk.
- •Pregnancy or nursing mother.
- •Woman in childbearing age without satisfactory contraception.
- •Hypersensitivity to lidocaine or amide-type local anesthetic drugs.
- •Active herpes zoster lesion or dermatitis of any origin at the affected site with PHN.
- •Evidence of another cause for pain in the area affected by herpes zoster in addition to PHN, such as lumbar radiculopathy, surgery or trauma, if this could confound assessment or self-evaluation of the pain due to post herpetic neuralgia.
- •Participants who had neurological ablation by block or neurosurgical intervention for control of pain in PHN.
- •Participants using topically applied analgesic compounds on the PHN affected area.
- •Presence of other severe pain that could confound assessment or self-evaluation of the pain due to PHN.
- •Participants with severe hepatic disorder and/or alanine or aspartate aminotransferase equal to or above 3-fold the upper limit of normal (ULN).
- •Participants with severe renal disorder and/or increased serum creatinine equal to or above 1.5-fold the upper limit of normal (ULN).
- •Participants who are undergoing active treatment for cancer, are known to be infected with the human immunodeficiency virus (HIV), or being acutely and intensively immunosuppressed following transplantation.
研究组 & 干预措施
Lido-Patch (Open-label Run-in Phase)
All participants applied up to 3 Lido-Patches (lidocaine 5% medicated plaster) per day (depending on the size of PHN area). Patches were applied topically for up to 12 hours per day (patch free interval: at least 12 hours) at the site of skin affected by painful PHN.
干预措施: Lidocaine 5% medicated Plaster (Drug)
Lido-Patch (Double-blind Phase)
Up to 3 patches (lidocaine 5% medicated plaster) per day (depending on the size of PHN area) were applied topically for up to 12 hours per day (patch free interval: at least 12 hours) at the site of skin affected by painful PHN.
干预措施: Lidocaine 5% medicated Plaster (Drug)
Placebo Patch (Double-blind Phase)
Up to 3 placebo plasters per day (depending on the size of PHN area) were applied topically for up to 12 hours per day (patch free interval: at least 12 hours) at the site of skin affected by painful PHN.
干预措施: Placebo Plaster (Drug)
结局指标
主要结局
Time-to-exit in Double-blind Phase Due to Lack of Efficacy
时间窗: From Day 1 until time to exit in Double-blind Phase (maximum Day 14)
The time to exit was defined as the number of days after randomization where worsening of the pain relief score by 2 or more categories on a 6-item pain relief scale (verbal rating scale, VRS) on 2 consecutive days in comparison to the average pain relief in Week 8 of the Run-in Phase was reported. The average pain relief in Week 8 of the enrichment phase was to be stated by the participant at the randomization visit. The VRS comprised the categories 1 = worse, 2 = no pain relief, 3 = slight, 4 = moderate, 5 = a lot, 6 = complete.
次要结局
- Daily Pain Intensity: NRS(From screening visit (Week -1) to end of Double-blind Phase visit (Week 10))
- Daily Pain Relief(From screening visit (Week -1) to end of Double-blind Phase visit (Week 10))
- Weekly Average 24-hour Pain Intensity: NRS(During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase))
- Weekly Worst Pain Intensity: NRS(During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase))
- Weekly Average Pain Intensity: NRS(During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase))
- Weekly Average Current Pain Intensity: NRS(During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase))
- Weekly Least Pain Intensity: NRS(During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase))
- Weekly Average Pain Relief: VRS(During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-bind Phase))