Health Condition 1: G629- Polyneuropathy, unspecified
Conditions
Interventions
Intervention1: FDC of Pregabalin SR 75 mg plus Mecobalamin 1500 mcg plus Nortriptyline 10 mg Tablets: One tablet once a day orally every night at bedtime for 12 weeks
Control Intervention1: FDC of Pre
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 and 65 years (both inclusive). 2. Patients with diagnosis of type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) = 6 months. 3. Patients total pain having intensity rating of at least 4 on a 0-10 points of numeric rating scale (NRS). 4. Patients with decreased Vitamin B12 levels ( 5. Patients with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 6. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to either of the study medications or any of its components. 2. Patients with prior therapy with Pregabalin or Nortriptyline, and having any other neurologic disorders unrelated to diabetic neuropathy were excluded. 3. Patients with abnormal eGFR ( 4. Patients with clinically significant impaired hepatic function. [SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL]. 5. Patients with known case of HIV, Hepatitis B & C within previous 3 months. 6. Patients with clinical laboratory evaluations (including biochemistry and hematology) and 12 lead ECG readings are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator. 7. Female patients who are pregnant or lactating or planning to become pregnant during the study period. 8. Females who are not ready to use acceptable contraceptive methods during the course of study. 9. Patients who, in the opinion of the investigator, have history of clinically significant cardiovascular disease (e.g. MI), central nervous system disorders (e.g. seizure, bipolar disorder, generalized anxiety disorder, untreated depression, psychosis or post-traumatic stress disorder), suicidal behavior, angle closure glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension. 10. Patients with known alcohol or other substance abuse within last one year. 11. Patients with medical history of Oncological Conditions since last 5 years. 12. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. 13. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 14. Participant has a clinically significant disorder that, in the opinion of the investigator, would result in the participantâ??s inability to understand and comply with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Numeric Rating Scale (NRS) from baseline to end of the study (12 weeks).Timepoint: Baseline, Day 14, Day 28, Day 56 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale from baseline to end of the study (12 weeks).Timepoint: Baseline, Day 14, Day 28, Day 56 and Day 84;Change in the Vitamin B12 levels from baseline to end of the study (12 weeks).Timepoint: Baseline and Day 84;Consumption of rescue medication (number of Paracetamol Tablets consumed).Timepoint: Baseline, Day 14, Day 28, Day 56 and Day 84;Investigator Global Assessment at the end of the study (12 weeks).Timepoint: Day 84;Patient Global Assessment at the end of the study (12 weeks).Timepoint: Day 84;The assessment of tolerability of investigational product will be based on incidence of AEs and SAEs and changes in laboratory values.Timepoint: Baseline, Day 14, Day 28, Day 56 and Day 84 | — |
Countries
India
Contacts
Public ContactRahul Vij
Synokem Pharmaceuticals Ltd.
Outcome results
None listed