Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: FDC of Pregabalin 75 mg plus Methylcobalamin 1500 mcg plus Duloxetine DR 20 mg Capsule and Matching Placebo Tablet: One capsule and one tablet once a day orally every night at bedtime f
Sponsors
Ravenbhel Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female subjects between 18 to 75 years of age (both inclusive). 2. Subjects with a diagnosis of type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) =12% and having pain associated with diabetic peripheral neuropathy= 3 months. 3. Subjects with pain intensity = 4 on 0-10 points of visual analog scale (VAS). 4. Subjects with decreased vitamin B12 levels ( 5. Subjects who are willing to sign written informed consent for participation in the study. 6. Subjects willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with hypersensitivity to either of the study medications or any of the ingredients of the formulation. 2. Patients with prior therapy with Pregabalin or Duloxetine or Nortriptyline and having any other neurologic disorders unrelated to diabetic peripheral neuropathic pain were excluded. 3. Patients with clinically significant impaired hepatic function. [SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL]. 4. Subject with abnormal eGFR ( 5. Subjects with Serum creatinine more than 1.5X the ULN. 6. Patients with any abnormality on 12 lead ECG readings and the results are deemed clinically significant by the investigator. 7. Subjects with a history of HIV, Hepatitis B & C. 8. Female patients who are pregnant or lactating or planning to become pregnant during the study period. 9. Females who are not ready to use acceptable contraceptive methods during the course of study. 10. Subjects who, in the opinion of the investigator, have a history of clinically significant cardiovascular disease (e.g. MI), subjects who are on pacemakers, central nervous system disorders (e.g. seizure, bipolar disorder, generalized anxiety disorder, untreated depression, psychosis or post-traumatic stress disorder), suicidal behavior, glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension, bleeding disorders. 11. Subjects with history of suicidal thoughts and behavior. 12. Subjects with serum sodium level 13. Subjects with uncontrolled hypertension with sitting SBP = 160 mmHg and/or DBP = 100 mmHg at screening. 14. Patient treated with topical or systemic pain medications within past 2 weeks prior to baseline. 15. Subjects with known alcohol or other substance abuse. 16. Subjects with a medical history of Oncological Conditions. 17. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. 18. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 19. Participant has a clinically significant disorder that, in the opinion of the investigator, would result in the participant’s inability to understand and comply with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in visual analog scale (VAS) from baseline to end of the treatment. (12 weeks)Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale from baseline to end of treatment. (12 weeks). Change in the Patient global impression of change scores (PGIC) from baseline to end of the treatment. (12 Weeks). Change in Vitamin B12 level from baseline to end of the treatment. (12 Weeks) Consumption of rescue medication (number of Paracetamol Tablets consumed) during the study.Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Ravindra Mote
Mediclin Clinical Research
Outcome results
None listed