Overview

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

Status:
Unknown status
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bunker Industria Farmaceutica Ltda.
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
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;