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

Primary Purpose

Neuralgia

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Bunker Industria Farmaceutica Ltda.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia focused on measuring Neuralgy, Dexamethasone, Complex Vitamins, Injection, Symptoms of neuralgy of various origins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Faculdade de Medicina do ABC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexamethasone and complex vitamins

Dexamethasone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy evaluation Likert scale and Visual Analogue

Full Information

First Posted
July 22, 2009
Last Updated
July 23, 2009
Sponsor
Bunker Industria Farmaceutica Ltda.
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1. Study Identification

Unique Protocol Identification Number
NCT00944502
Brief Title
To Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bunker Industria Farmaceutica Ltda.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia
Keywords
Neuralgy, Dexamethasone, Complex Vitamins, Injection, Symptoms of neuralgy of various origins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone and complex vitamins
Arm Type
Experimental
Arm Description
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.
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Vitatonus dexa tablest, Vitatonus Dexa Injectable
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Efficacy evaluation Likert scale and Visual Analogue
Time Frame
Ten days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Hasan
Organizational Affiliation
Faculdade de Medicina do ABC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09060650
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Hasan
Phone
55 1149935469
Email
r.hasan@terra.com.br
First Name & Middle Initial & Last Name & Degree
Rosa Hasan

12. IPD Sharing Statement

Learn more about this trial

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

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