ACTRN12615000013561已完成2 期
A Randomized, Double-Blind, Crossover, Phase IIa Study Comparing a Single-Application TPM/Oxycodone Patch versus Vehicle Patch in the Topical Treatment of Patients with Postherpetic Neuralgia
Phosphagenics Pty Ltd0 个研究点目标入组 28 人开始时间: 2015年1月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients with moderate to severe PHN pain present for at least 6 months after onset of herpes zoster (HZ) skin rash at the time of Screening.
- •Patients must have a NPRS average pain over the last 24 hours of more than 3 and less than 10 for 3 consecutive days prior to Baseline Visit
- •Patients must be willing and able to stop all protocol prohibited chronic current pain therapy for the duration of study
排除标准
- •Significant pain due to causes other than PHN
- •PHN painful areas located only on the face, above hairline of scalp, and / or in proximity to mucous membranes.
- •Any history of a dermatological condition or recurrent generalized skin disorder in the area to be treated within the last 5 years, including psoriasis, eczema or any other skin condition that might interfere with study assessments.
- •Current or recent use of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, aspirin, menthol, methyl salicylate, local anesthetics (including Lidoderm(registered trademark) patch), steroids, low-concentration capsaicin products on the painful areas within 3 days prior to Baseline assessment of pain and during the study.
- •Receiving treatment with more than one high dose medication for pain, such as anticonvulsants, within 10 days prior to Baseline assessment of pain and during the study.
- •Use of opioids (e.g. oxycodone, tramadol) within 10 days prior to Baseline assessment of pain and during the study.
- •Use of Central Nervous System (CNS) depressants including: neuroleptics, tranquillizers, skeletal muscle relaxants, sedating antihistamines within 30 days prior to Baseline assessment of pain and during the study. Exception: short acting night sedatives like benzodiazepines and non-benzodiazepines in small doses (e.g. sleep aids for insomnia) are allowed in consultation with the Medical Monitor (MM).
- •Antidepressant medications are allowed for anxiety and depression, if given on stable doses for a minimum of 6 months prior to Baseline assessment of pain and during the study. Such treatments should not be changed during the study without consultation with the MM. Exception: (TCA in dose up to 75 mg/ day or duloxetine [60 mg maximum daily] or venlafaxine [150 mg daily]) are permitted during the study
- •Use of neurotropin, N-methyl-D-aspartate receptor antagonists (dextromethorphan, ketamine, memantine, etc), muscle relaxants, sodium channel blockers (mexiletine, etc), centrally acting sympatholytic agents (clonidine, etc), and prostaglandin and related products (prescribed for PHN) 30 days prior to Baseline assessment of pain and during the study.
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