Health Condition 1: G64- Other disorders of peripheral nervous system
Conditions
Interventions
Intervention1: FDC of Pregabalin IP 75 mg and Nortriptyline 10 mg: FDC of Pregabalin IP 75 mg and Nortriptyline 10 mg once daily for 4 weeks
Control Intervention1: nil: nil
Sponsors
Micro Labs Limited
Micro Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in mean pain scoreTimepoint: week 0, week 2, week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in daily pain related symptoms scale SIRS scaleTimepoint: week 0, week 2, week 4;Improvement in Patients Global Impression of Change (PGIC)Timepoint: week 0, week 2, week 4 | — |
Countries
India
Contacts
Public ContactDr Krishna Kumar M
Micro Labs Limited
Outcome results
None listed