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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00944502

Enrollment

104

Registered

2009-07-23

Start date

2009-10-31

Completion date

2009-12-31

Last updated

2009-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuralgia

Keywords

Neuralgy, Dexamethasone, Complex Vitamins, Injection, Symptoms of neuralgy of various origins

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.

Interventions

DRUGDexamethasone

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	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

Measure	Time frame
Efficacy evaluation Likert scale and Visual Analogue	Ten days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026