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

NCT00944502 | Unknown Phase 3 DMC

• 1 other identifier: E03-BUN-VITD-02/07
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuralgia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy evaluation Likert scale and Visual Analogue

  Ten days

Study Arms (2)

Dexamethasone and complex vitamins

EXPERIMENTAL

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

Dexamethasone

ACTIVE COMPARATOR

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

Interventions

Dexamethasone DRUG

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.

Also known as: Vitatonus dexa tablest, Vitatonus Dexa Injectable

Dexamethasone; Dexamethasone and complex vitamins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bunker Industria Farmaceutica Ltda.: lead

Study Sites (1)

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060650, Brazil

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Rosa Hasan

  Faculdade de Medicina do ABC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 23, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 24, 2009

Record last verified: 2009-07

Locations

BR (1)