Risk of Shopping Behavior of Tapentadol IR Immediate-Release (IR) Compared to Oxycodone IR Immediate-Release (IR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 646,620
- 主要终点
- Proportion of patients who developed shopping behavior defined as patients with prescriptions with at least one day of overlap, written by ≥ 2 different prescribers and filled in 3 or more pharmacies
研究概览
简要总结
The purpose of this study is to compare the risk of shopping behavior of tapentadol immediate release with the risk of shopping behavior of oxycodone immediate release.
详细描述
This is a retrospective (a study that looks backward in time, usually using medical records and interviews with patients) matched cohort (designated group followed or traced over a period of time) study using IMS LRx database. This database covers 65% of all retail prescriptions in the United States and includes mail service and specialty pharmacy provider prescriptions independent of the method of payment. The study will include Opioid naive patients exposed to tapentadol immediate release (IR) or oxycodone IR from July 2009 to December 2010. A naive patient is a patient who has not received an opioid of any type in the 3 months before the index date. The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009. Patients will be followed for 1 year from their index dates. Each tapentadol IR-exposed patient will be matched to up to 4 oxycodone IR-exposed patients. Matching will allow to control in the design for potential confounding variables such as time of the exposure, geographic area, specialty of the prescriber, and age. These are variables that have been related with the risk of shopping behavior or abuse.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Opioid naive patients (a patient who has not received an opioid of any type in the 3 months before the index date) exposed to tapentadol IR or oxycodone IR from July 2009 to December 2010 [The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009]
排除标准
- •Patients with use of any opioid 3 months before the index date
- •Patients who within 4 days on or after the index date fill a prescription for a different opioid
- •Patients who within 4 days on or after the index date fill a prescription for the same opioid but written by a different prescriber
研究组 & 干预措施
Tapentadol IR
干预措施: Tapentadol IR (Drug)
Oxycodone IR
干预措施: Oxycodone IR (Drug)
结局指标
主要结局
Proportion of patients who developed shopping behavior defined as patients with prescriptions with at least one day of overlap, written by ≥ 2 different prescribers and filled in 3 or more pharmacies
时间窗: 12 months
次要结局
- Time to first episode of shopping behavior(12 months)
- The number of shopping episodes during the year of follow up(12 months)
- The type of dispensing in the first episode of shopping event(12 months)