NCT02228928已完成1 期
Efficacy and Safety of 0.625% and 1.25% Capsaicin Patch in the Management of Peripheral Neuropathic Pain ; Early Phase II, Multi-center, Randomized, and Semi-double Blind Controlled Clinical Trial
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean difference in the change of daily NRS pain score
研究概览
简要总结
The efficacy and safety of the low concentration [0.65% (50 µg/cm2) and 1.25% (100 µg/cm2)] capsaicin patches and compared them to conventional 0.075% capsaicin cream and placebo patch in patients suffering from peripheral neuropathy
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
- Double (Participant, Investigator)
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
- •patients who are 18 years of age or older aged having chronic peripheral neuropathy related with a diagnosis of either PHN or DPN
- •patients with chronic peripheral neuropathic pain for more than 3 months with an 11-pointed Numeric Rating Scale (NRS) pain score ≥ 4
- •patients with a diagnosis of PHN were eligible if at least 3 months had elapsed since shingles vesicle crusting
- •patients with DPN and well controlled diabetes were asked to maintain a stable dose of oral hypoglycemic or insulin during the study period
- •patients taking concomitant pain medications such as anticonvulsants, antidepressants, anxiolytics, and opioids including tramadol were required to maintain a stable dose for at least 4 weeks before the study enrollment
- •any conservative therapies such as TENS, physical therapy, chiropractic, massage, biofeedback, or yoga were stopped at least 5 weeks before the enrollment
- •women of childbearing age were required to have a negative pregnancy test and were to be willing to use an effective method of contraception for at least 28 days after the last exposure to study medication
排除标准
- •diffusely distributed neuropathic pain resulting from spinal stenosis, postoperative origin, complex regional pain syndrome, or genetic neurological disease, or significant pain outside the target area
- •significant pain of an etiology other than PHN or DNP
- •other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or with investigational product administration or may interfere with compliance or the interpretation of study results andin the judgment of the investigator would make the subject inappropriate to participate in the study
- •painful PHN areas located on the face or above the scalp hairline
- •an implanted medical device for the treatment of neuropathic pain
- •use of topically applied agents including capsaicin-containing products, a 5% lidocaine patch or similar products, local anesthetics, or steroids within the past 21 days
- •hypersensitivity known to capsaicin; current use of any class 1 anti-arrhythmic drug; and uncontrolled diabetes mellitus or uncontrolled hypertension
- •If patients have taken oral NSAID or COX2 Inhibitor, it should be stopped at least2 weeks before randomization; however acetaminophen for pain control was allowed up to 4g per day
研究组 & 干预措施
CAPNP, 50 ug/cm2 capsaicin patch
Experimental
50 ug/cm2 capsaicin patch, 49cm2, 1patch/4days
干预措施: CAPNP, 50 ug/cm2 capsaicin patch (Drug)
CAPNP, 100 ug/cm2 capsaicin patch
Experimental
100ug/cm2 capsaicin patch, 49cm2, 1patch/4days
干预措施: CAPNP, 100 ug/cm2 capsaicin patch (Drug)
0.075% capsaicin cream
Active Comparator
capsaicin cream qc/day
干预措施: 0.075% capsaicin cream (Drug)
Placebo patch
Placebo Comparator
干预措施: Placebo patch (Other)
结局指标
主要结局
Mean difference in the change of daily NRS pain score
时间窗: 6 weeks
Mean numeric change in numerical rating scale pain score from the baseline (Visit 2) to the score at weeks 6 (Visit 5) in each group
次要结局
- EQ-5D(6 weeks)
- Daily Sleep Interference Scale(2, 4, 6 weeks)
- Percentage of patients with >=30% or >=50% reduction in pain(6 weeks)
- Clinical Global Impression for Improvement(2, 4, 6 weeks)
研究者
研究点 (1)
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