Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

Novartis

Status and phase: Completed; Phase 4

Conditions: Neuropathic Pain

Treatments: Drug: Carbamazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01089855

CTEG111ZMA01

Details and patient eligibility

About

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

Enrollment: 123 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

Carbamazepine

Experimental group

Treatment:

Drug: Carbamazepine