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

July 23, 2009 updated by: Bunker Industria Farmaceutica Ltda.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060650
        • Faculdade de Medicina do ABC
        • Contact:
        • Principal Investigator:
          • Rosa Hasan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone and complex vitamins

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

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.

Other Names:
  • Vitatonus dexa tablest
  • Vitatonus Dexa Injectable
Active Comparator: 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.
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.

Other Names:
  • Vitatonus dexa tablest
  • Vitatonus Dexa Injectable

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Ten days
Ten days

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy evaluation Likert scale and Visual Analogue
Time Frame: Ten days
Ten days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bunker Industria Farmaceutica Ltda.

Investigators

  • Principal Investigator: Rosa Hasan, Faculdade de Medicina do ABC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

July 22, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Estimate)

July 24, 2009

Last Update Submitted That Met QC Criteria

July 23, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E03-BUN-VITD-02/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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