Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 17
- 主要终点
- Evaluate the within-group differences (baseline to 6 mo.) in pain alleviation (using the 11 point numerical rating scale) in patients with pDPN and FM in real-world settings with a PA versus no PA policy in place restricting access to
研究概览
简要总结
The investigators hypothesize that fibromyalgia (FM) and painful diabetic peripheral neuropathy (pDPN) patients with access restrictions on pregabalin will lead to higher healthcare resource use and cost compared to patients without such restrictions on pregabalin in a naturalistic setting. The randomization will occur at the physician level and not the patient level.
详细描述
This trial was terminated prematurely on April 2, 2012, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A physician-confirmed diagnosis of either pDPN or FM, but not both.
- •Initiation of a medication for pDPN or FM is clinically indicated, either as monotherapy or in combination with other treatments, as determined by the treating physician, and agreed to by the patient.
- •No prior pregabalin use or pregabalin PA requests.
排除标准
- •Age < 18 years at time of study enrollment.
- •Females or are partners of males currently pregnant/lactating or intending to become pregnant in the next 6 months
- •Physician-confirmed diagnosis of both pDPN and FM.
结局指标
主要结局
Evaluate the within-group differences (baseline to 6 mo.) in pain alleviation (using the 11 point numerical rating scale) in patients with pDPN and FM in real-world settings with a PA versus no PA policy in place restricting access to
时间窗: 6 months
Quantify the between-group difference (baseline to 6 mo.) in direct all-cause medical costs for patients with pDPN and FM in real-world treatment settings with a prior authorization (PA) versus no PA policy in place restricting access to
时间窗: 6 months
pregabalin
时间窗: 6 months
pregabalin.
时间窗: 6 months
次要结局
- Describe how pharmacologic treatment patterns for pDPN or FM differ between groups with PA and without PA in patients being treated in a naturalistic outpatient care setting, and who are followed for 6 mo.(6 months)
- Describe non-pharmacologic treatment patterns in pDPN and FM patients in groups with PA versus no PA while being treated in a naturalistic outpatient care setting, and who are followed for 6 mo.(6 months)
- Subset of patients who have at least 6 mo. pre-study time in the HIRD (HealthCore Integrated Research DatabaseSM) a within-group costs analysis (all cause) comparing pre-study healthcare utilization costs for the 6 mo. pre-baseline with on-study(6 months)
- Compare the within-group differences (baseline to 6 mo.) in pain alleviation (using the NRS-11 scale) between groups (PA versus no PA), by condition (pDPN or FM).(6 months)
- healthcare utilization costs (baseline to 6 mo.).(6 months)
- Assess changes (baseline through 6 mo.) in other PRO measures in pDPN and FM patients subject to PA requirements for pregabalin versus those with no PA.(6 months)