“An Open Label, Prospective, Multicentric, Single Arm, Active Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of FDC of Pregabalin 75 mg plus Nortriptyline 10 mg Tablets in Adult Patients for the Treatment of Neuropathic Pain.â€
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 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
Thistrial is an open label, prospective, multicentric, single arm, active postmarketing surveillance study to evaluate the safety and efficacy of FDC of Pregabalin 75 mg plusNortriptyline 10 mg Tablets in adult patients for the treatment of neuropathic pain.
All the patientsbeing prescribed the medication will be enrolled in the study. Patients will beadvised to take one tablet once a day orally every night at bedtime for 90days. Follow up visits will be done on day 45±5 and day 90±5 (Final Visit) oftreatment to assess safety 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
- •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 plus Nortriptyline 10 mg Tablets as part of their routine treatment regimen.
排除标准
- •Patients with known hypersensitivity to Pregabalin / Nortriptyline.
- •Females of child bearing 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: At Day 45±5 and Day 90±5.
次要结局
- Improvement in Numeric Rating Scale (NRS) from baseline to end of the study.(At Day 1, Day 45 and Day 90)
- Consumption of rescue medication (number of other analgesic tablets consumed).(At Day 45 and Day 90)
- Overall safety and efficacy of the study medication at the end of the study.(At Day 90)