A post-marketing surveillance study to assess the safety and efficacy of Pregabalin IP 75 mg and Nortriptyline 10 mg Tablets in diabetic peripheral neuropathy

Micro Labs Limited0 个研究点目标入组 203 人开始时间: 待定最近更新: 2023年2月6日

试验速览

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•1. Presence of type 2 diabetes mellitus
•2. No change in anti-diabetic medication for the past 1 month
•3. Evidence of painful diabetic neuropathy by:
•i.Neuropathic pain present for at least 1 month.
•ii.Mean pain intensity of more than 50% by patient assessment by NRS (numerical rating scale)
•4. Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol specific procedures are performed

•1. Pregnancy and lactation.
•2. Subjects having intolerance, hypersensitivity or any other contraindication to any of the Investigational products.
•3. Evidence of other causes for neuropathy and painful conditions
•4. Epilepsy, psychiatric and cardiac diseases, hypertensives not on treatment, peripheral vascular disease and substance abuse.
•5. Intake of any other anticonvulsants, antidepressants, membrane stabilizers and opioid
•6. Patients who have participated in another clinical study in the past 3 months prior to commencement of this study
•7. Subjects judged unfit for this study by investigator.

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