Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

Novartis123 enrolled

Overview

The trial is designed to evaluate the efficacy and tolerability of carbamazepine in neuropathic pain in diabetic patients

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Neuropathic Pain

Interventions

CarbamazepineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetes patients with Diabetes neuropathy DN4 \> or equal to 4 * Male or female aged from 21 to 65 years * Informed consent * HbA1C \< 11% Exclusion Criteria: * Prior Hospitalization for Acido- cetosis * Prior hospitalization for severe hypoglycemia * Pregnancy * Hepatitis * Diabetes foot * AVB (auriculo-ventricular conduction disturbance) * Patient treated by antidepressant drugs * Patient treated with other antiepileptic drug * Patients with blood ion disturbance * Patient with neutropenia * Glaucoma * Bladder Adenoma * Alcohol abuse * Creatinin clearance \< 60 ml/ minute Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis Investigational Site

Rabat, Morocco

Outcomes

Primary Outcomes

The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)

Time frame: 12 weeks

Secondary Outcomes

Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding)

Time frame: 12 weeks

Evaluate the quality of life

Time frame: 12 weeks

Data from ClinicalTrials.gov

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