Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

Overview

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

Full Title of Study: “Phase IV Open Non Comparative Trial to Evaluate Efficacy and Safety of Tegretol® in Diabetes Neuropathy Pain.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2010

Interventions

  • Drug: Carbamazepine

Arms, Groups and Cohorts

  • Experimental: Carbamazepine

Clinical Trial Outcome Measures

Primary Measures

  • The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)
    • Time Frame: 12 weeks

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • External Affairs, Novartis Pharmaceuticals
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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