Health Condition 1: - Health Condition 2: G00-G99- Diseases of the nervous system
Conditions
Interventions
Intervention1: Fixed Dose Combination of Gabapentin 400mg and Nortriptyline HCl 10mg Tablet: 1 Unit of Fixed Dose Combination of Gabapentin 400mg and Nortriptyline HCl 10mg Tablet twice daily for 24 w
Sponsors
Sunglow Life Science Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Men and women of at least 18 years of age willing to give informed consent for the study. 2) Patients diagnosed with peripheral neuropathy who have abnormalities in 2 of 3 categories (signs, symptoms, and objective tests of nerve conduction studies or quantitative sensory threshold testing). 3) Patients with peripheral neuropathy associated with diabetes that is stable and controlled (HbA1C = than 10 %) with no new symptoms associated with diabetes within previous 3 months. 4) Patients with at least mild painful symptoms of diabetic neuropathy for at least 1 year duration, but not longer than 10 years duration 5) Patients on pain medication (prescribed analgesics), stable for atleast 3 months before study entry or pain treatment naive. 6) Patients having Toronto Clinical Neuropathy Score (TCNS) = 6 at screening/ baseline visit(Day 1/ Week 0)
Exclusion criteria
Exclusion criteria: 1) Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control. 2) Escalating or changing pain condition within the past month as evidenced by investigator examination. 3) Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days. 4) Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months. 5) Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump. 6) Subjects currently has an active infection. 7) Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates participation in this clinical trial. 8) Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: a) Change from baseline in peroneal motor nerve conduction velocity at week 0 (Visit 1) and week 24. b) Change from baseline in patient-reported responses to Toronto Clinical Neuropathy Score (TCNS) at week 0 (Visit 2) and week 24.Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: a) Change from baseline in quality of life administered by SF-36 Questionnaire instrument at week 0 (Visit 2), Week 12 and week 24 (Patient global impression of quality of life assessed by the SF-36 short form) b) Adverse events will be assessed during the entire duration of the study. Laboratory end points will be assessed prior to treatment and at the end of treatment. ? Clinical - Incidence of adverse events ? Biochemical - o Liver function tests (Bilirubin, SGOT, SGPT, ALP) o Renal function tests (Urea, creatinine) o Urine ExaminationTimepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappan
iDD Research Solutions Pvt. Ltd
Outcome results
None listed