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;