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
Overview
- Phase
- Phase 3
- Intervention
- Dextralgen
- Conditions
- Lumbar Sciatic Pain
- Sponsor
- Eurofarma Laboratorios S.A.
- Enrollment
- 280
- Locations
- 6
- Primary Endpoint
- efficacy
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
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.
Arms & Interventions
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
Intervention: Dextralgen
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.
Intervention: Meloxicam
Outcomes
Primary Outcomes
efficacy
Time Frame: 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.