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
  Purpose

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.


Condition Intervention Phase
Neuralgia
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bunker Industria Farmaceutica Ltda.:

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 [ Time Frame: Ten days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy evaluation Likert scale and Visual Analogue [ Time Frame: Ten days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 104
Study Start Date: October 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944502

Locations
Brazil
Faculdade de Medicina do ABC Not yet recruiting
Santo André, São Paulo, Brazil, 09060650
Contact: Rosa Hasan    55 1149935469    r.hasan@terra.com.br   
Principal Investigator: Rosa Hasan         
Sponsors and Collaborators
Bunker Industria Farmaceutica Ltda.
Investigators
Principal Investigator: Rosa Hasan Faculdade de Medicina do ABC
  More Information

No publications provided

Responsible Party: Elaine Pessoa, Bunker Indústria Farmacêutica Ltda.
ClinicalTrials.gov Identifier: NCT00944502     History of Changes
Other Study ID Numbers: E03-BUN-VITD-02/07
Study First Received: July 22, 2009
Last Updated: July 23, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Bunker Industria Farmaceutica Ltda.:
Neuralgy
Dexamethasone
Complex Vitamins
Injection
Symptoms of neuralgy of various origins

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014