Tolerability of QUTENZATM When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 20
- 主要终点
- The proportion of subjects who tolerate QUTENZA treatment
研究概览
简要总结
The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.
详细描述
All patients will be treated with QUTENZA for 60 minutes. Patients will be randomized to one of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic (tramadol oral tables) prior to application of QUTENZA. Patients will be followed up for 7 days to monitor pain scores and tolerability.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of postherpetic neuralgia or neuropathic pain due to peripheral nerve injury
- •Daily pain score ≥ 4 for average pain both at the Screening Visit and at the Treatment Visit
- •Intact, non-irritated, dry skin over the painful area(s) to be treated
排除标准
- •Significant ongoing or recurrent pain other than due to PHN or peripheral nerve injury
- •Past or current history of Type I or Type II diabetes mellitus
- •Active malignancy or treatment for malignancy within a year prior to the Treatment Visit
研究组 & 干预措施
Tramadol
Tramadol prior to QUTENZA
干预措施: QUTENZA (Drug)
Tramadol
Tramadol prior to QUTENZA
干预措施: Tramadol (Drug)
Lidocaine
Lidocaine prior to QUTENZA
干预措施: QUTENZA (Drug)
Lidocaine
Lidocaine prior to QUTENZA
干预措施: Lidocaine (Drug)
结局指标
主要结局
The proportion of subjects who tolerate QUTENZA treatment
时间窗: 60 minute application period
A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration.
次要结局
- Duration of patch application(60 minutes)
- Change in pain scores from baseline to subsequent timepoints on the day of patch application(5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3)
- Proportion of subjects using pain medications and dose of pain medication(s) administered(day 1-5)
- Subject rated tolerability score(Baseline to end of study visit, day 7)