Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China: A Retrospective, Database, Multi-center Study (ReTARdant)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,271
- 试验地点
- 10
- 主要终点
- Proportion of participants who restarted treatment after discontinuation in participants with DPNP or CIPN
研究概览
简要总结
The aim of this study is to investigate the pharmacological treatment pattern among patients with diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) in China.
详细描述
Diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) are common subtypes of neuropathic pain. The treatment pattern, subsequent medication usage, and adherence information of medication among these patients are still not clear. There is also an unmet need for the use of relevant analgesic medications in this area. This real-world data study aims to understand patients' characteristics, clinical diagnosis and treatment patterns, medication adherence, real-world effectiveness among DPNP and CIPN patients in China and will explore the current unmet needs of DPNP and CIPN, in order to inform physicians' decision-making in clinical practice
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of participants who restarted treatment after discontinuation in participants with DPNP or CIPN
时间窗: From index date up to 31st December 2022
Among those who had discontinued treatment, the proportion of patients who received at least one targeted medication at the next visit will be assessed, where the treatment regimen containing the targeted medication includes the same treatment medication prior to discontinuation or a different treatment medication after treatment switch/add-on.
Duration of the current treatment in participants with DPNP or CIPN
时间窗: From index date up to 31st December 2022
Duration of the current treatment is defined as the time interval from the start date of a treatment to its end date. The end date of the treatment refers to its discontinuation date; for participants who did not experience a treatment discontinuation, the end date of treatment prescription is used.
Proportion of participants who discontinue/switch/add-on treatment and related medication categories in participants with DPNP or CIPN
时间窗: From index date up to 31st December 2022
Treatment discontinuation is defined as the time interval between two adjacent treatment regimens, or the time interval between the end of the last treatment regimen and the study end date (31st December 2022), or the time interval between the end of the last treatment regimen and the date of death is ≥90 days. Treatment switch is defined as the change of treatment regimen, either in monotherapy or in combination (exclude treatment add-on). Treatment add-on is defined as the addition of one or more targeted medications to an existing treatment regimen (monotherapy or combination therapy).
Proportion of participants receiving different treatment regimens (targeted medications or combinations) and related medication categories in participants with DPNP or CIPN
时间窗: From index date up to 31st December 2022
The treatment regimen will be evaluated and confirmed as monotherapy or combination therapy based on prescription records at each visit. Monotherapy is defined as participants only received one targeted medication. Combination therapy is defined as participants received more than one targeted medication at the same time.
Time to treatment add-on in participants with DPNP or CIPN
时间窗: From index date up to 31st December 2022
Time to treatment add-on is defined as the time interval between the end date of the current treatment regimen (including days covered by take-away medications) and the start date of the add-on treatment.
次要结局
- Initial daily dose in participants with DPNP or CIPN(From index date up to 31st December 2022)
- Maximum daily dose in participants with DPNP or CIPN(From index date up to 31st December 2022)
- Proportion of participants who underwent the daily dose change in participants with DPNP or CIPN(From index date up to 31st December 2022)
- Time to the maximum daily dose in participants with DPNP or CIPN(From index date up to 31st December 2022)