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

NCT01147289 | Completed Phase 3

• 1 other identifier: EF 102
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 6

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).

Conditions

Lumbar Sciatic Pain

Keywords

lumbar sciatic pain; moderate to severe lumbar sciatic pain within the last three days

Outcome Measures

Primary Outcomes (1)

• efficacy

  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.

  6 months

Study Arms (2)

dexalgen

EXPERIMENTAL

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

Drug: Dextralgen

Meloxicam

ACTIVE COMPARATOR

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

Drug: Meloxicam

Interventions

Dextralgen DRUG

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.

dexalgen

Meloxicam DRUG

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.

Meloxicam

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (6)

CEDOES

Vitória, Espírito Santo, 29055-450, Brazil

Location

Sociedade Beneficente São Camilo

Campinas, São Paulo, 05022-001, Brazil

Location

Instituto De Pesquisa Clínica De Campinas IPECC

Campinas, São Paulo, 13073-350, Brazil

Location

Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA

São Paulo, São Paulo, 05437-010, Brazil

Location

Hospital Santa Marcelina

São Paulo, São Paulo, 08270-070, Brazil

Location

Faculdade de Medicina ABC

São Paulo, São Paulo, 0960-650, Brazil

Location

MeSH Terms

Interventions

Meloxicam

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Carlos Gorios, Phd./MD

  Sociedade Beneficente São Camilo

  PRINCIPAL INVESTIGATOR

• Paulo Guilherme Oliveira e Silva, Phd/MD

  Hospital Santa Marcelina

  PRINCIPAL INVESTIGATOR

• Luciana Teixeira Pinto, Phd/MD

  Instituto de Pesquisa Clínica e Medicina Avançada (IMA)

  PRINCIPAL INVESTIGATOR

• Sergio Raj Eis, Phd/MD

  CEDOES

  PRINCIPAL INVESTIGATOR

• Jose Alexandre Mendonça, Phd/MD

  Instituto de Pesquisa Clínica de Campinas (IPECC)

  PRINCIPAL INVESTIGATOR

• Sonia Maria Silva, Phd/MD

  Faculdade de Medicina ABC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 22, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: April 1, 2012
• Last Updated: March 28, 2025

Record last verified: 2012-05

Locations

BR (6)