CTRI/2024/01/062148
Recruiting
Phase 3
A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Gabapentin SR plus Methylcobalamin plus Nortriptyline film-coated bilayered tablets Versus FDC of Gabapentin SR Plus Methylcobalamin film-coated tablets in patients with peripheral neuropathic pain with coexistent Vitamin B12 deficiency. - NI
Ravenbhel Healthcare Pvt. Ltd.0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: G63- Polyneuropathy in diseases classified elsewhere
- Sponsor
- Ravenbhel Healthcare Pvt. Ltd.
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The study aims to evaluate patients aged 18\-75 with neuropathic pain, Gabapentin and Methylcobalamin treatment, decreased Vitamin B12 levels, and non\-specific symptoms like allodynia, burning, shooting, or hyperalgesia.
- •Participants must sign an informed consent document and adhere to all protocol procedures.
Exclusion Criteria
- •Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •Patients using gabapentin for any other neurologic disorders unrelated to peripheral neuropathic pain.
- •Patient taking any other medication for the treatment of peripheral neuropathic pain last two weeks.
- •Patients with a diagnosis of type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) \>11%.
- •Patients with abnormal eGFR ( \<60 mL/min/1\.73 m2\).
- •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].
- •Any abnormality on 12\-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
- •Ongoing administration of Monoamine Oxidase (MAO) inhibitors.
- •Patients with medical history of Oncological Conditions.
- •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.
Outcomes
Primary Outcomes
Not specified
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