ACTRN12617000206325招募中2 期
A double blind, placebo controlled, randomized crossover, pilot study of topical RM191A spray for the relief of neuropathic pain
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 22
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
- •1, Male/female patient aged 18 years or older, with moderate to severe neuropathic pain present for at least 3 months.
- •2. Affected area is appropriate for topical treatment.
- •3. Skin is intact over the area to be treated.
- •4. Pain must be due to neuropathic pain that, in the opinion of the Investigator, is of an appropriate severity for treatment.
- •5. Patient must have appropriate NPRS average pain over the last 24 hours for at least 3 of the 7 days prior to the Baseline Visit.
- •6. Prior pain medications expected to be continued at current level for the duration of the study.
排除标准
- •1. Significant pain due to causes other than neuropathic pain.
- •2. Any history of a dermatological condition or recurrent generalized skin disorder in the area to be treated within last 5 years, inclduing psoriasis, eczema or any other skin condition that might interfere with study assessments.
- •3. Change in dose of long acting opioids or adjuvant analgesic medications within 7 days of the screening visit, during the screening period prior to baseline assessment of pain and/or during the study.
- •4. Current or recent use of any topically applied non-opioid pain medications on the painful areas within 3 days prior to Baseline assessment of pain and during the study.
- •5. Known allergy to copper.
- •6. Known diagnosis of WIlson's Disease.
研究者
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