NCT02205229暂停不适用
Compounded Pain Preparation Absorption Study (ComPPAS)
Medimix Specialty Pharmacy, LLC1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Serum concentration of ingredients used in multi-ingredient, topical compounded medications
研究概览
简要总结
Single center, prospective, observational study to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy.
详细描述
Single center, prospective, observational, open-label, cohort study of participants that receive a combination topical pain medication from Medimix Specialty Pharmacy with no comparator group designed to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must apply and consistently use the supplied cream for 1 month at a prescribed
- •Participants must be ≥ 30 and <65 years of age
- •Participants must be able to provide sound written and verbal informed consent
- •Participants must be diagnosed with an ICD9 code indicative of chronic pain
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
- •Participants must not have used any study drug greater than 180 days from the day of Screening
- •Participants must not be utilizing medications that may interact with those being used in the topical formulation as determined by the PI
- •Participants must not be using any systemic medications that may influence drug serum concentrations of ingredients being used in the topical compound. These include medications from the same class of studied drugs or drugs that may falsely increase or decrease serum levels of the study drugs
研究组 & 干预措施
Patients receiving a topical compounded medication
干预措施: Multi-ingredient, topical compounded medications (Drug)
结局指标
主要结局
Serum concentration of ingredients used in multi-ingredient, topical compounded medications
时间窗: 1 Month
次要结局
未报告次要终点
研究者
研究点 (1)
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