A retrospective multicentre observational study to assess the patient profile for the fixed dose combination of Methylcobalamin, duloxetine and pregabalin, in Indian patients with Diabetic Peripheral Neuropathy - (BLUE FEATHER DPN)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12,500
- 试验地点
- 3
- 主要终点
- 1. To understand epidemiological profile of patients of diabetic peripheral neuropathy, naïve or switching over to Pregabalin, Duloxetine & Methylcobalamin FDCs
研究概览
简要总结
Diabetes is a serious chronic disease and a leading cause of death globally, accounting for an estimated four million deaths in 2017. The global prevalence of diabetes was 9.3% (463 million people) in 2019, projected to rise to 10.9 Percent (700 million) by 2045. In India, an estimated 77 million people were living with diabetes in 2019, expected to exceed 134 million by 2045. The growing diabetic population has led to a surge in chronic complications, particularly Diabetic Peripheral Neuropathy (DPN), one of the most common and disabling conditions. No curative therapies currently exist for DPN; treatments focus on symptom control and slowing progression. First-line pharmacological options for painful DPN include pregabalin, duloxetine, and amitriptyline, among others. Vitamin B12 (Methylcobalamin) deficiency has been linked to peripheral neuropathy due to its role in nerve function and myelin sheath maintenance. Despite frequent clinical use, there is a lack of large-scale Indian data on real-world prescribing patterns and patient profiles for these FDCs.
This study proposes a retrospective clinic-based analysis of approximately 12,500 patients from 500 outpatient clinics across India to better understand the real-world use of pregabalin, duloxetine, and Methylcobalamin FDCs in the management of DPN. Patients who were prescribed FDC of Pregabalin, Duloxetine, Methylcobalamin FDCs (any dosage) will be included for the study and the following variables will be considered for analysis-
-
Demographic variables such as: Age, Sex, Weight, Height
-
Percentage of new patients who were prescribed triple FDC
- Percentage of patients on monotherapy switched over to triple FDC and switched from which therapy
- Percentage of patients on dual therapy switched over to triple FDC and switched from which therapy
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with Diabetic Peripheral Neuropathy
- •Patients who were prescribed FDC of Pregabalin, Duloxetine, Methylcobalamin FDCs (any dosage).
排除标准
- 未提供
结局指标
主要结局
1. To understand epidemiological profile of patients of diabetic peripheral neuropathy, naïve or switching over to Pregabalin, Duloxetine & Methylcobalamin FDCs
时间窗: Baseline
次要结局
- 1. Percentage of new patients who were prescribed triple FDC(2. Percentage of patients on monotherapy switched over to triple FDC & switched from which therapy)
研究者
Dr Lokesh R V
Torrent Pharmaceuticals Ltd.