Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

Phase 4

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: Carbamazepine

• Registration Number: NCT01089855
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-19
• Primary Completion: 2010-07
• Status Verified: 2011-02
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carbamazepine	Carbamazepine	-

Primary Outcome Measures

Name	Time	Method
The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding)	12 weeks
Evaluate the quality of life	12 weeks

Trial Locations

Locations (1)

Novartis Investigational Site; 🇲🇦 Rabat, Morocco