An Open Label, Prospective, Non-comparative,Multicentric,Single Arm, Active Post Marketing Surveillance Study to Evaluate the Safety, Tolerability and Efficacy of FDC of Pregabalin 75 mgand Nortriptyline 10 mg Tablets in Adult Patients for the treatment of Neuropathic Pain.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.
研究概览
简要总结
This trial is an open-label, prospective, non-comparative, multicentric, single-arm, active post-marketing surveillance study to evaluate the safety, tolerability and efficacy of FDC of Pregabalin 75 mg and Nortriptyline 10 mg Tablets in Adult Patients for the treatment of neuropathic pain.
All the patients being prescribed the medication will be enrolled in the study. As this is an active post-marketing surveillance study to evaluate the safety, tolerability and efficacy of the drug manufactured by Aeon Formulations Pvt. Ltd, free samples will be given to all the patients to ensure that the patients do not change the test product being used. Follow up visits will be done on day 45±7 and day 90±7 (Final Visit) of treatment to assess safety, tolerability and efficacy
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults male or female patients aged 18 to 65 years (both inclusive), diagnosed with neuropathic pain and who require treatment with FDC of Pregabalin 75 mg and Nortriptyline 10 mg Tablets as part of their routine treatment regimen.
排除标准
- •Patients with known hypersensitivity to Pregabalin / Nortriptyline.
- •Females of childbearing age not using effective contraception/nursing & pregnant females.
- •Patients predisposed to Thrombocytopenia / liver dysfunction / renal impairment.
- •Patients with known history of myocardial infarction (MI) / cardiac arrhythmia.
结局指标
主要结局
Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.
时间窗: 3 Months
次要结局
- Improvement in Numeric Rating Scale (NRS) from baseline to end of the study.(3 Months)