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

Phase 3

• Conditions: Neuralgia
• Interventions: Drug: Dexamethasone

• Registration Number: NCT00944502
• Lead Sponsor: Bunker Industria Farmaceutica Ltda.

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Last Update Submitted: 2009-07-23
• Last Update Posted: 2009-07-24
• Study Start: 2009-10
• Primary Completion: 2009-11
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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.

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone and complex vitamins	Dexamethasone	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	Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Efficacy evaluation Likert scale and Visual Analogue	Ten days

Trial Locations

Locations (1)

Faculdade de Medicina do ABC; 🇧🇷 Santo André, São Paulo, Brazil