Clinical trial NCT01147289: Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain
Official title: A Phase III, Randomized, Multicenter, Open Label Clinical Trial: Efficacy and Safety of the Injectable Association of Dexamethasone, Dipyrone, and Hydrocobalamin in Lumbar Sciatic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lumbar Sciatic Pain
Keywords: lumbar sciatic pain
moderate to severe lumbar sciatic pain within the last three days
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. The study will enroll 140 patients in each arm (280 total).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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.

Primary outcomes:
measure: efficacy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vitoria
country: Brazil
facility: CEDOES
state: Espirito Santo
city: Campinas
country: Brazil
facility: Sociedade Beneficente São Camilo
state: São Paulo
city: Campinas
country: Brazil
facility: Instituto De Pesquisa Clínica De Campinas IPECC
state: São Paulo
city: São paulo
country: Brazil
facility: Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
city: São Paulo
country: Brazil
facility: Faculdade de Medicina ABC
Study officials:
affiliation: Sociedade Beneficente São Camilo
name: Carlos Gorios, Phd./MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Santa Marcelina
name: Paulo Guilherme Oliveira e Silva, Phd/MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Pesquisa Clínica e Medicina Avançada (IMA)
name: Luciana Teixeira Pinto, Phd/MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CEDOES
name: Sergio Raj Eis, Phd/MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Pesquisa Clínica de Campinas (IPECC)
name: Jose Alexandre Mendonça, Phd/MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade de Medicina ABC
name: Sonia Maria Silva, Phd/MD
role: PRINCIPAL_INVESTIGATOR
References: