NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions In Denmark
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 主要终点
- Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview
研究概览
简要总结
Observational study to assess the effectiveness and use of pregabalin (Lyrica) in the treatment of patients with peripheral neuropathic pain in real-life daily clinical practice.
详细描述
General practitioners and specialists participate in the study. When a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral NeP, the subject can (before first dose of pregabalin is taken) be included in the observational program.
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
- •Subjects aged 18 years or over.
- •Subjects diagnosed with peripheral neuropathic pain.
- •Subjects that independently of the study and before consideration for observation in the study have been prescribed pregabalin for treatment of peripheral neuropathic pain either.
- •for the first time ('first prescription patients') or
- •that have not used pregabalin within the previous 6 months but are prescribed pregabalin again ('re-treatment patients')
- •Subjects that haven't taken the first dose of the prescribed pregabalin yet.
排除标准
- •Subjects not consenting to participate.
- •Subjects that at study inclusion (baseline) are on treatment with pregabalin for generalized anxiety or epilepsy.
结局指标
主要结局
Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview
时间窗: Baseline, Month 3 Telephonic Interview
Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Change From Baseline In Average Pain Level At Month 3 Telephonic Interview
时间窗: Baseline, Month 3 Telephonic Interview
Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Change From Baseline In Least Pain Level At Month 3 Telephonic Interview
时间窗: Baseline, Month 3 Telephonic Interview
Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
次要结局
- Work Productivity and Activity Impairment (WPAI) Questionnaire(Baseline, Month 1, 2, 3)
- Pregabalin Dose(After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview)
- Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)(Month 3 telephonic interview)
- Sleep Interference Scale Score(Baseline, Month 1, 2, 3, Month 3 telephonic interview)
- Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)(After Baseline, Month 1, 2, 3 visit)
- Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit(Before Baseline, Month 1, 2, 3 Visit)
- Health-related Quality of Life Scale Score(Baseline, Month 1, 2, 3)