Health Condition 1: E104- Type 1 diabetes mellitus with neurological complications Health Condition 2: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Pregabalin Gel 8% and
Placebo Capsule: Topical Pregabalin Gel 8% of Lyka Labs Ltd. twice a day. and
Placebo Capsule one capsule thrice a day of Healcure Life sciences for 63 days
Cont
Sponsors
Lyka Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either gender between 18 to 75 years (both inclusive). 2.Diagnosis of chronic diabetic neuropathic pain restricted only to feet area by investigator before at least 1 month of screening. 3.Patient having daily pain in lower extremity in one or both the legs. 4.Patients having pain score greater than or equal to 4 on Visual Analogue Scale (VAS) of 0-10 at the time of screening and on day of enrolment (after washout period of seven days). 5.Score of 12 or more on Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score 6.HbA1c concentration should be less than 12.2 % at screening. 7.Provides written informed consent in accordance with applicable regulatory requirements.
Exclusion criteria
Exclusion criteria: 1.Proliferative retinopathy or maculopathy requiring acute treatment. 2.Requiring dialysis. 3.Impaired liver function 4.Vitamin B12 level below 180 ng/L or uncontrolled hypothyroidism in spite of adequate treatment. 5.Patients with any orthopedic alteration of any extremity. 6.Patients with peripheral artery disease. 7.Patients taking more than two diabetic neuropathic pain medicines 8.Patients who are receiving treatment with anti-depressants, antiepileptics 9.Patients with uncontrolled Angle-closure glaucoma. 10.A coexisting disorder causing pain as severe as the diabetic neuropathic pain. 11.Women of childbearing potential not receiving an effective form of contraception. 12.Pregnant woman or lactating mother. 13.Known hypersensitivity to Pregabalin, or any of its ingredients. 14.Patient who requires treatment with a drug that prolongs QT interval such as Cardiac medications like Antiarrhythmic drugs Class Ia (Quinidine, Procainamide, Disopromide), Class III (Dofetilide, Ibutilide, Sotalol) Non-cardiac medications like Antihistamines (Terfenadine, Astemizole), Antipsychotic and antidepressant agents, Neuroleptic (Haloperidol, Droperidol, Thioridazine, Chlorpromazine), Atypical antipsychotics (Sertindole, Ziprasidone, Risperidone, Zimeldine, Citalopram), Antidepressants (Amitriptyline, Desipramine, Imipramine, Maprotiline, Doxepin, Fluoxetin)Antibiotics like Quinolone (Sparfloxacin, Levofloxacin, moxifloxacin, grepafloxacin) and Macrolide (Erythromycin, Clarithromycin) Antimalarials (Quinine, halofantrine) Antiprotozoal(Pentamidine)Antifungal (Azole group) Antimotility Agents (Cisapride) Methadone 15.Creatinine clearance = 60 ml/min or known case of renal impairment. 16.Clinically significant laboratory abnormalities at the time of screening. 17.Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week. 18.Patients participated in any type of clinical study within the last 30 days of the screening date. 19.Unsuitability for enrollment otherwise as decided by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.=50 % change in Visual Analogue Scale (VAS).Timepoint: At the Screening visit (Day-10 to Day-7), Visit 2(Day1), Visit 3 (Day 36) & at the end of study (Day 63) Visual Analogue Scale (VAS) will be performed . | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)=50 % change in Leeds Assessment of Neuropathic Symptoms (Appendix-4). 2)=50 % change in Patient Global Impression of Change (PGIC) (0-7) (Appendix-5). 3)=50 % change in Clinicians Global Impression of change (CGIC) (0-7) (Appendix-6). 4)=50 % change in DN4 Questionnaire (Appendix-7). 5)=50 % change in Quality of life Questionnaire (Appendix-8). 6)=50 % change in Sleep Disturbance – Adults Scale. (Appendix-9).Timepoint: At the Screening visit (Day-10 to Day-7) & at the end of study (Day 63) these scales will be performed. | — |
Countries
India
Contacts
Public ContactDr Viral Shah
Lyka Labs Private Limited
Outcome results
None listed