Status:
COMPLETED
Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Lumbar Sciatic Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
A phase III, randomized, multicenter, open label clinical trial to evaluate efficacy and safety of the injectable association of dexamethasone, dipyrone, and hydroxocobalamin in lumbar sciatic pain. T...
Eligibility Criteria
Inclusion
- Sign the study informed consent form;
- 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
- o-Diagnosed with chronic rheumatologic diseases, except recurrent lumbar sciatic pain;
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT01147289
Start Date
February 1 2011
End Date
April 1 2012
Last Update
March 28 2025
Active Locations (6)
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1
CEDOES
Vitória, Espírito Santo, Brazil, 29055-450
2
Sociedade Beneficente São Camilo
Campinas, São Paulo, Brazil, 05022-001
3
Instituto De Pesquisa Clínica De Campinas IPECC
Campinas, São Paulo, Brazil, 13073-350
4
Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA
São Paulo, São Paulo, Brazil, 05437-010