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

Bunker Industria Farmaceutica

Status and phase: Unknown; Phase 3

Conditions: Neuralgia

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00944502

E03-BUN-VITD-02/07

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 2 patient groups

Dexamethasone and complex vitamins

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

Dexamethasone

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone