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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
104 participants
INTERVENTIONAL
2009-10-31
2009-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
ALL
No
Sponsors
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Bunker Industria Farmaceutica Ltda.
INDUSTRY
Responsible Party
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Bunker Indústria Farmacêutica Ltda.
Principal Investigators
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Rosa Hasan
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina do ABC
Locations
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Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Countries
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Facility Contacts
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Other Identifiers
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E03-BUN-VITD-02/07
Identifier Type: -
Identifier Source: org_study_id
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