Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain
NCT ID: NCT01147289
Last Updated: 2025-03-28
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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COMPLETED
PHASE3
280 participants
INTERVENTIONAL
2011-02-28
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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dexalgen
Dexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose for 3 days, at least
Dextralgen
Dexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.
Meloxicam
Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose for at least 3 days.
Meloxicam
Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.
Interventions
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Dextralgen
Dexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.
Meloxicam
Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.
Eligibility Criteria
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Inclusion Criteria
* To be diagnosed with moderate to severe lumbar sciatic pain (defined as limiting the work activities or the ordinary tasks performance or at the investigator's discretion) within the last 3 days;
* Aged 18 to 75 years old;
* To be able to meet the study procedures
Exclusion Criteria
* Patients with one of the following conditions, as per the investigator's criteria:
* Severe renal failure under hemodialysis, severe liver failure, uncontrolled severe heart failure;
* Severe injuries on gastrointestinal tract;
* Other severe comorbidities;
* Patients taking acetylsalicylic acid or any anti-clotting;
* Female patients who are pregnant, lactating, willing to get pregnant or not willing to use an appropriate contraceptive method during the study period.
18 Years
75 Years
ALL
No
Sponsors
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Eurofarma Laboratorios S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Carlos Gorios, Phd./MD
Role: PRINCIPAL_INVESTIGATOR
Sociedade Beneficente São Camilo
Paulo Guilherme Oliveira e Silva, Phd/MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Santa Marcelina
Luciana Teixeira Pinto, Phd/MD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Pesquisa Clínica e Medicina Avançada (IMA)
Sergio Raj Eis, Phd/MD
Role: PRINCIPAL_INVESTIGATOR
CEDOES
Jose Alexandre Mendonça, Phd/MD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Pesquisa Clínica de Campinas (IPECC)
Sonia Maria Silva, Phd/MD
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina ABC
Locations
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CEDOES
Vitória, Espírito Santo, Brazil
Sociedade Beneficente São Camilo
Campinas, São Paulo, Brazil
Instituto De Pesquisa Clínica De Campinas IPECC
Campinas, São Paulo, Brazil
Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA
São Paulo, São Paulo, Brazil
Hospital Santa Marcelina
São Paulo, São Paulo, Brazil
Faculdade de Medicina ABC
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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EF 102
Identifier Type: -
Identifier Source: org_study_id
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