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

Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00944502
• Other study ID #: E03-BUN-VITD-02/07
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 22, 2009
• Last updated: July 23, 2009
• Start date: October 2009
• Est. completion date: December 2009

Study information

• Verified date: July 2009
• Source: Bunker Industria Farmaceutica Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia

Intervention

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.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Bunker Industria Farmaceutica Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation of adverse events related to medication. The causality of adverse events concerning the use of medication will be given after applying the Naranjo Algorythm		Ten days	Yes
Secondary	Efficacy evaluation Likert scale and Visual Analogue		Ten days	Yes