Prescriber Based, Post Marketing Surveillance Study (PMS) to generate safety and efficacy data of Pregabalin and Nortriptyline tablets
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary objective of this PMS is to evaluate safety and tolerability of this FDC in treatment of painful peripheral neuropathy in the actual field conditions of use.
研究概览
简要总结
The fixed dose combination oral tablet of Pregabalinand Nortriptyline is being marketed in India for the treatment of peripheralneuropathic pain.
The primary objective of this PMS is to evaluatesafety and tolerability of this FDC in treatment of painful peripheralneuropathy in the actual fieldconditions of use. The secondary objective of this PMS is to evaluate efficacy ofthis FDC in treatment of painful peripheral neuropathy in the actual field conditions of use.
All patientsclinically manifesting with symptoms of painful peripheral neuropathy and who have been prescribed Pregabalin & Nortriptyline TABLET in the recommended doses will be assessed for safety & efficacy.Patients will usually be called for follow-up on the day convenient tothem and will be judged on the bases of enquiry & clinician impression.
Adverse event reporting will be done using PMS formsupplied by Medical Representative. Patients will be questioned about anyadverse experience during the treatment period (Both anticipated and unexpected side effects)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex of age 18 to 60 years [both inclusive] 2.Willing to give written informed consent 3.All patients clinically manifesting with symptoms of painful peripheral neuropathy.
排除标准
- •Patients known, or thought to be hypersensitivity to study drug 2)History of auto-immune disease 3)Concurrent use of corticosteroids 4)Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion 5)Participation in other clinical trials the last three months and during study participation 6)Patients with history of epilepsy, or those at risk for seizures or taking seizure drugs 7)Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control 8)Patients with galactose or fructose intolerance 9)Patients with severe renal impairment, including those receiving dialysis.
- •Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
- •Patients with preexisting gallbladder disease 12)Active peptic ulcer disease.
结局指标
主要结局
The primary objective of this PMS is to evaluate safety and tolerability of this FDC in treatment of painful peripheral neuropathy in the actual field conditions of use.
时间窗: 7 days
次要结局
- The secondary objective of this PMS is to evaluate efficacy of this FDC in treatment of painful peripheral neuropathy in the actual field conditions of use(7 days)