Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

NCT ID: NCT01089855

Last Updated: 2017-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Neuropathic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carbamazepine

Group Type EXPERIMENTAL

Carbamazepine

Intervention Type DRUG

Interventions

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Carbamazepine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigational Site

Rabat, , Morocco

Site Status

Countries

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Morocco

Other Identifiers

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CTEG111ZMA01

Identifier Type: -

Identifier Source: org_study_id

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