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OpenTrials
Completed

NCT Number: NCT01089855

Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

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

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigational Site

Rabat, Morocco

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbamazepine

Drug

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
First posted
Mar 19, 2010
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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