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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Bunker Industria Farmaceutica Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bunker Industria Farmaceutica Ltda.
ClinicalTrials.gov Identifier:
NCT00944502
First received: July 22, 2009
Last updated: July 23, 2009
Last verified: July 2009

July 22, 2009
July 23, 2009
October 2009
November 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
  • The causality of adverse events concerning the use of medication will be given after applying the Naranjo Algorythm [ Time Frame: Ten days ] [ Designated as safety issue: Yes ]
  • Observation of adverse events related to medication [ Time Frame: Ten days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00944502 on ClinicalTrials.gov Archive Site
Efficacy evaluation Likert scale and Visual Analogue [ Time Frame: Ten days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Neuralgia
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
  • 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.

    Intervention: Drug: Dexamethasone
  • 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.

    Intervention: Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
104
December 2009
November 2009   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Not Provided
Brazil
 
NCT00944502
E03-BUN-VITD-02/07
Yes
Elaine Pessoa, Bunker Indústria Farmacêutica Ltda.
Bunker Industria Farmaceutica Ltda.
Not Provided
Principal Investigator: Rosa Hasan Faculdade de Medicina do ABC
Bunker Industria Farmaceutica Ltda.
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP