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Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 4
Locations
Morocco
Study Type
Interventional
Intervention
Carbamazepine
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic Pain, Brief Pain Inventory, DN4 questionnaire, ElectroCardioGram

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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/exclusion criteria may apply

Sites / Locations

  • Novartis Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carbamazepine

Arm Description

Outcomes

Primary Outcome Measures

The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)

Secondary Outcome Measures

Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding)
Evaluate the quality of life

Full Information

First Posted
March 17, 2010
Last Updated
July 10, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01089855
Brief Title
Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain
Official Title
Phase IV Open Non Comparative Trial to Evaluate Efficacy and Safety of Tegretol® in Diabetes Neuropathy Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Neuropathic Pain, Brief Pain Inventory, DN4 questionnaire, ElectroCardioGram

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbamazepine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Carbamazepine
Primary Outcome Measure Information:
Title
The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding)
Time Frame
12 weeks
Title
Evaluate the quality of life
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigational Site
City
Rabat
Country
Morocco

12. IPD Sharing Statement

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Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

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