Trial | NCT00944502  Report issue

Title

To Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins
Multicenter Clinical Study, Phase III, Prospective, Randomized, Double-blind, Comparative to Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    urea ...

  • Study Participants

    104
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 nature, with a patients diagnosed with neuralgia of diverse origin.

Patients will be include in sufficient quantity to achieve the minimum of 104 evaluable patients.
Study Started
Oct 31
2009
Primary Completion
Nov 30
2009
Anticipated
Study Completion
Dec 31
2009
Anticipated
Last Update
Jul 24
2009
Estimate

Drug Dexamethasone

Group A: Vitatonus DEXA injectable: 1 ampoule intramuscularly every 3 days for 10 days. Group B: Vitatonus DEXA tablets: 1 tablet orally every 8 hours for 10 days. Group C: Dexamethasone Injectable: 1 ampoule intramuscularly every 3 days for 10 days. Group D: Dexamethasone tablets: 1 tablet orally every 8 hours for 10 days.

  • Other names: Vitatonus dexa tablest, Vitatonus Dexa Injectable

Dexamethasone and complex vitamins Experimental

Group A: Vitatonus dexa injectable: 1 ampoule intramuscularly every 3 days for 10 days. Group B: Vitatonus DEXA tablet: 1 tablet orally every 8 hours for 10 days.

Dexamethasone Active Comparator

Group C: Dexamethasone Injectable: 1 ampoule intramuscularly every 3 days for 10 days. Group D: Dexamethasone tablet: 1 tablet orally every 8 hours for 10 days.

Criteria 

Inclusion Criteria:

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 Criteria:

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;
No Results Posted