Status:

UNKNOWN

To Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins

Lead Sponsor:

Bunker Industria Farmaceutica Ltda.

Conditions:

Neuralgia

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

To evaluate the efficacy and tolerability of Vitatonus Dexa compared with dexamethasone in the signs and symptoms of neuralgia of various origins. Clinical study, randomized prospective and random in...

Eligibility Criteria

Inclusion

  • Patients who consent to participate in the study by signing the ICF;
  • Patients of any ethnic group of both sexs aged over 18 years;
  • Patients with clinical diagnosis of neuralgia of various origins.
  • Patients who present scores on the Visual Analogue Scale (VAS) greater than or equal to 4 for PAIN.

Exclusion

  • Patients with known hypersensitivity to lidocaine and thiamine or any component of the formula;
  • Pregnant women and nursing mothers;
  • Hypertensive or cardiac patients;
  • Patients with history of ulcers in the stomach or duodenum, diabetes mellitus or severe infections;
  • Patients who use levodopa, salicylates, colchicine, aminoglycosides, chloramphenicol, anticonvusivantes or potassium supplement.
  • Patient with a history of alcohol or use illicit drugs;

Key Trial Info

Start Date :

October 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2009

Estimated Enrollment :

104 Patients enrolled

Trial Details

Trial ID

NCT00944502

Start Date

October 1 2009

End Date

December 1 2009

Last Update

July 24 2009

Active Locations (1)

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Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil, 09060650