Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain (Dextra)

Eurofarma

Status and phase: Completed; Phase 3

Conditions: Lumbar Sciatic Pain

Treatments: Drug: Meloxicam; Drug: Dextralgen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01147289

EF 102

Details and patient eligibility

About

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).

Enrollment: 280 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

280 participants in 2 patient groups

dexalgen

Experimental group

Description:

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

Treatment:

Drug: Dextralgen

Meloxicam

Active Comparator group

Description:

Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose for at least 3 days.

Treatment:

Drug: Meloxicam