Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

Phase IV Open Non Comparative Trial to Evaluate Efficacy and Safety of Tegretol® in Diabetes Neuropathy Pain.

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

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