Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago

Overview

The purpose of this study is to assess the efficacy end tolerability of a new drug containing the combination meloxicam and cyclobenzaprine (7,5/10mg) and the same components alone in the treatment of acute lumbago.

Full Title of Study: “A Phase III, Randomized, Single-Blind, Superiority Study Comparing The Efficacy And Tolerability Of A New Drug Containing The Combination Meloxicam And Cyclobenzaprine And The Same Components Alone In The Treatment Of Acute Lumbago”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: May 2013

Detailed Description

To assess the efficacy and tolerability of a new drug containing the combination meloxicam and cyclobenzaprine in the treatment of acute lumbago, compared to the same components alone.

Some eligibility criteria:

Have a normal X-ray of the lumbar spine for the age; Have a baseline score in the VAS higher than or equal to 40 mm

Interventions

  • Drug: meloxicam/cyclobenzaprine hydrochloride
    • two oral capsules a day during approximately 07 days
  • Drug: meloxicam – Movatec®
    • two oral tablet a day during approximately 07 days
  • Drug: cyclobenzaprine – Miosan®
    • two oral tablet a day during approximately 07 days

Arms, Groups and Cohorts

  • Active Comparator: meloxicam – Movatec®
  • Active Comparator: cyclobenzaprine – Miosan®,
  • Experimental: meloxicam/cyclobenzaprine hydrochloride

Clinical Trial Outcome Measures

Primary Measures

  • Pain Reduction
    • Time Frame: Pain reduction 3 days after the administration of study drugs
    • Compare the treatment groups for the efficacy in pain reduction, 3 days after the administration of study drugs, when compared to the baseline assessment.

Secondary Measures

  • Frequency of rescue medication use
    • Time Frame: During study treatment, an expected average of 7days
    • Assessment of frequency of rescue medication use, as well as the proportion of patients during study treatment;

Participating in This Clinical Trial

Inclusion Criteria

  • Sign, initial and date the Informed Consent Form (ICF);
  • Be between 18 and 75 years old;
  • Have acute lumbago with onset in less than 72 hours;
  • Have a normal X-ray;
  • Have a baseline score in the VAS higher than or equal to 40 mm;

Exclusion Criteria

  • Use of triptans;
  • Use of monoamine oxidase inhibitors;
  • Use of NSAIDs within the last week;
  • Previous use of narcotics;
  • Have any rheumatologic disease;
  • Conditions of chronic pain;
  • Have any significant chronic comorbidity;
  • Previous history of gastrointestinal bleed or ulcers;
  • History of allergy to any of the components of study medications;
  • Recent history of a myocardial infarction, cardiac arrhythmia, cardiac conduction block or change, or congestive heart failure;
  • Female patients who are pregnant or breastfeeding or who wish to become pregnant or who deny using safe contraceptive methods during the study will not be enrolled in the study;
  • Have participated in another clinical trial within the last 12 months.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eurofarma Laboratorios S.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alceu Chueiri, Principal Investigator, Hospital de Base de São José do Rio Preto
    • Paulo Guilherme, Principal Investigator, Hospital Santa Marcelina
    • Wagner Caiafa, Principal Investigator, Santa Casa de Juiz de Fora
    • Antonio Scotton, Principal Investigator, Centro MIneiro de Pesquisa – Juiz de Fora
    • Lindomar G. Oliveira, Principal Investigator, Clínica de Ortopedia e Fraturas de Goiania
    • Antonio Carlos Ximenes, Principal Investigator, CIP Pesquisas Médicas Ltda
    • Sonia Alvarenga, Principal Investigator, Faculdade de Medicina ABC
    • Gilberto Brandão, Principal Investigator, Clínica Perdizes
    • Luciana Teixeira, Principal Investigator, IMA Brasil – Instituto de Medicina Avançada
    • Antonio Tarcísio, Principal Investigator, Santa Casa de Misericórdia de Belo Horizonte
    • Carlos Roberto Galia, Principal Investigator, Hospital de Clínicas de Porto Alegre
    • Mauro Hernandes, Principal Investigator, Santa Casa de Votuporanga

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