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NCT01089855 Clinical Trial

Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01089855
Other study ID # CTEG111ZMA01
Secondary ID
Status Completed
Phase Phase 4
First received March 17, 2010
Last updated July 10, 2017
Start date December 2009

Study information
Verified date February 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Carbamazepine

Locations
Country Name City State
Morocco Novartis Investigational Site Rabat

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Morocco, 

Outcome
Type Measure Description Time frame Safety issue
Primary The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI) 12 weeks
Secondary Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding) 12 weeks
Secondary Evaluate the quality of life 12 weeks
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