NCT01862848已完成不适用
Topical Compounded Pain Creams And Pain Perception (TOPCAPP)
Medimix Specialty Pharmacy, LLC1 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2012年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Perceived pain changes
研究概览
简要总结
To evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen.
详细描述
This is a prospective,observational,single center, open label study of patients that receive a combination topical compounded analgesic medication with no comparator group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be diagnosed with an ICD9 code indicative of chronic pain.
- •Participants must be starting a new regimen of topical therapy with multiple compounded agents.
- •Participants must be expecting to receive therapy for at least 12 weeks.
- •Participants must be between 18 and 65 years of age.
- •Participants must be able to provide sound written and verbal informed consent.
排除标准
- •Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.
- •Participants must not be pregnant or breastfeeding women.
- •Participants must not have a diagnosis of cancer within the past 5 years.
结局指标
主要结局
Perceived pain changes
时间窗: 12 Week Study [Baseline, 4,8, and 12 week evaluation]
Minimal sample size of 60 persons(maximum n=150)with a diagnosis of chronic pain (n=30 neuropathic and n=30 nociceptive primary pain-type)to determine predictors of a 30% or greater reduction of pain scores evaluated by logistic regression analyses utilizing the Brief Pain Index scores.
次要结局
- Quality of Life(12 Weeks [Baseline,4,8, and 12 week evaluation])
研究者
研究点 (1)
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