Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Carbamazepine

Criteria

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