Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Pregabalin ointment 8% w/w: Topical Pregabalin 8% w/w
2 FTU per affected area per application (Approx. 4.0 gm on affected feet area per day) to be applied in a thin film twice a day.
C
Sponsors
Lyka Labs Ltd
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 percent 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 nanogram per Litter 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 oral Pregabalin or Gabapentin. 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 Less than equal to 60 ml/min or known case of renal impairment. 16. Clinically significant laboratory abnormalities at the time of screening as per Principal Investigator discretion. 17. Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse will be defined as more than 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. To evaluate the Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) of Pregabalin Gel 8 % w/w 2. To evaluate the Local Tolerability of Pregabalin Gel 8 % w/wTimepoint: At Visit 2 (Day 30 +-2 days), Visit 3 Day (63 +-2 days) SAE and AE data will be collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| change in Visual Analogue Scale Change in DN4 questionnaire score at end of treatment as compared to baseline change in Quality of life scale at end of treatment as compared to baseline scoresTimepoint: Baseline Day 30 Day 63 | — |
Countries
India
Contacts
Public ContactDr Viral Shah
Lyka Labs Private Limited
Outcome results
None listed