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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neuralgia

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who consent to participate in the study by signing the ICF; Patients of any ethnic group of both sexs aged over 18 years; Patients with clinical diagnosis of neuralgia of various origins. Patients who present scores on the Visual Analogue Scale (VAS) greater than or equal to 4 for PAIN. Exclusion Criteria: Patients with known hypersensitivity to lidocaine and thiamine or any component of the formula; Pregnant women and nursing mothers; Hypertensive or cardiac patients; Patients with history of ulcers in the stomach or duodenum, diabetes mellitus or severe infections; Patients who use levodopa, salicylates, colchicine, aminoglycosides, chloramphenicol, anticonvusivantes or potassium supplement. Patient with a history of alcohol or use illicit drugs;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone and complex vitamins<br>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. | Drug: Dexamethasone<br>* 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.<br>* Other names: Vitatonus Dexa Injectable;|
| Active Comparator: Dexamethasone<br>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. | Drug: Dexamethasone<br>* 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.<br>* Other names: Vitatonus Dexa Injectable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy evaluation Likert scale and Visual Analogue |  | Ten days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuralgy, Dexamethasone, Complex Vitamins, Injection, Symptoms of neuralgy of various origins