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

NCT01147289 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-03-28

No results posted yet for this study

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).

Conditions

  • Lumbar Sciatic Pain

Interventions

DRUG

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. Both drugs will be administered for 3 days, at least.

DRUG

Meloxicam

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

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Principal Investigators

  • Carlos Gorios, Phd./MD · Sociedade Beneficente São Camilo

  • Paulo Guilherme Oliveira e Silva, Phd/MD · Hospital Santa Marcelina

  • Luciana Teixeira Pinto, Phd/MD · Instituto de Pesquisa Clínica e Medicina Avançada (IMA)

  • Sergio Raj Eis, Phd/MD · CEDOES

  • Jose Alexandre Mendonça, Phd/MD · Instituto de Pesquisa Clínica de Campinas (IPECC)

  • Sonia Maria Silva, Phd/MD · Faculdade de Medicina ABC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-11-30
Completion
2012-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01147289 on ClinicalTrials.gov