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Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

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ClinicalTrials.gov Identifier: NCT01089855
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : July 13, 2017
Sponsor:
Information provided by:
Novartis

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

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Carbamazepine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Open Non Comparative Trial to Evaluate Efficacy and Safety of Tegretol® in Diabetes Neuropathy Pain.
Study Start Date : December 2009
Actual Primary Completion Date : July 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Carbamazepine Drug: Carbamazepine


Outcome Measures
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Primary Outcome Measures :
  1. The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding) [ Time Frame: 12 weeks ]
  2. Evaluate the quality of life [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089855


Locations
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Morocco
Novartis Investigational Site
Rabat, Morocco
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:
Clinical Trial Results for CTEG111ZMA01 at Novartis Clinical Trials.com  This link exits the ClinicalTrials.gov site

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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01089855     History of Changes
Other Study ID Numbers: CTEG111ZMA01
First Posted: March 19, 2010    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: February 2011
Keywords provided by Novartis:
Neuropathic Pain
Brief Pain Inventory
DN4 questionnaire
ElectroCardioGram
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Carbamazepine
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers