Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain
- Registration Number
- NCT01147289
- Lead Sponsor
- Eurofarma Laboratorios S.A.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- 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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dexalgen 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 for 3 days, at least Meloxicam 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.
- Primary Outcome Measures
Name Time Method efficacy 6 months The efficacy analysis will be at the per protocol population, with the VAS measure after three treatment dosages. The VAS scale consists on a straight line of 100 mm in which the patient marks, at any point through the straight line, the point he/she considers to describe the pain level he/she feels. After the patient marks the straight line, classifying his/her pain, it is measured with a millimeter-graded standard rule, the distance between the mark and the extremity "No pain" at the scale.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Hospital Santa Marcelina
🇧🇷São Paulo, Brazil
Instituto De Pesquisa Clínica De Campinas IPECC
🇧🇷Campinas, São Paulo, Brazil
Sociedade Beneficente São Camilo
🇧🇷Campinas, São Paulo, Brazil
Faculdade de Medicina ABC
🇧🇷São Paulo, Brazil
CEDOES
🇧🇷Vitoria, Espirito Santo, Brazil
Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA
🇧🇷São paulo, Brazil