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

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

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).

Study Overview

• Status: Completed
• Conditions: Lumbar Sciatic Pain
• Intervention / Treatment: Drug: Dextralgen; Drug: Meloxicam

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 08270-070
    • Hospital Santa Marcelina
  • São Paulo, Brazil, 0960-650
    • Faculdade de Medicina ABC
  • São paulo, Brazil, 05437-010
    • Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA
  • Espirito Santo
    • Vitoria, Espirito Santo, Brazil, 29055-450
      • CEDOES
  • São Paulo
    • Campinas, São Paulo, Brazil, 05022-001
      • Sociedade Beneficente São Camilo
    • Campinas, São Paulo, Brazil, 13073-350
      • Instituto De Pesquisa Clínica De Campinas IPECC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: June 16, 2010
• First Submitted That Met QC Criteria: June 17, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Estimate): May 15, 2012
• Last Update Submitted That Met QC Criteria: May 14, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: lumbar sciatic pain; moderate to severe lumbar sciatic pain within the last three days
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: EF 102