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Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01089855
First received: March 17, 2010
Last updated: February 25, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Neuralgia
 Drug: Carbamazepine
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Open Non Comparative Trial to Evaluate Efficacy and Safety of Tegretol® in Diabetes Neuropathy Pain.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluate the quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: December 2009
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carbamazepine Drug: Carbamazepine

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089855

Locations
Morocco
Novartis Investigational Site
Rabat, Morocco
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01089855     History of Changes
Other Study ID Numbers: CTEG111ZMA01
Study First Received: March 17, 2010
Last Updated: February 25, 2011
Health Authority: Morocco: Ministry of Public Health

Keywords provided by Novartis:
Neuropathic Pain
Brief Pain Inventory
DN4 questionnaire
ElectroCardioGram

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Carbamazepine
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013