Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01089855

Enrollment

123

Registered

2010-03-19

Start date

2009-12-31

Completion date

Unknown

Last updated

2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain

Keywords

Neuropathic Pain, Brief Pain Inventory, DN4 questionnaire, ElectroCardioGram

Brief summary

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

Interventions

DRUGCarbamazepine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

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

Secondary

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

Countries

Morocco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026