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

NCT ID: NCT00944502

Last Updated: 2009-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuralgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vitatonus dexa tablest Vitatonus Dexa Injectable

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bunker Industria Farmaceutica Ltda.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bunker Indústria Farmacêutica Ltda.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rosa Hasan

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina do ABC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rosa Hasan

Role: primary

55 1149935469

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E03-BUN-VITD-02/07

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neuropathic Pain Management
NCT01263132 COMPLETED PHASE3
Steroids Versus Gabapentin
NCT01495923 COMPLETED NA