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

This study is not yet open for participant recruitment.
Verified April 2012 by Eurofarma Laboratorios S.A.
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01587508
First received: April 24, 2012
Last updated: April 26, 2012
Last verified: April 2012
History of Changes

April 24, 2012
April 26, 2012
November 2012
June 2013   (final data collection date for primary outcome measure)
Pain Reduction [ Time Frame: Pain reduction 3 days after the administration of study drugs ] [ Designated as safety issue: No ]
Compare the treatment groups for the efficacy in pain reduction, 3 days after the administration of study drugs, when compared to the baseline assessment.
Same as current
Complete list of historical versions of study NCT01587508 on ClinicalTrials.gov Archive Site
Frequency of rescue medication use [ Time Frame: During study treatment, an expected average of 7days ] [ Designated as safety issue: Yes ]
Assessment of frequency of rescue medication use, as well as the proportion of patients during study treatment;
Same as current
Not Provided
Not Provided
 
Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago
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

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Acute Lumbago
  • 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
  • Active Comparator: meloxicam - Movatec®
    Intervention: Drug: meloxicam - Movatec®
  • Active Comparator: cyclobenzaprine - Miosan®,
    Intervention: Drug: cyclobenzaprine - Miosan®
  • Experimental: meloxicam/cyclobenzaprine hydrochloride
    Intervention: Drug: meloxicam/cyclobenzaprine hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
471
September 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Camille R. da Silva 55 11 41449681 camille.rodrigues@eurofarma.com.br
Brazil
 
NCT01587508
EF 127
No
Eurofarma Laboratorios S.A.
Eurofarma Laboratorios S.A.
Not Provided
Principal Investigator: Alceu Chueiri Hospital de Base de São José do Rio Preto
Principal Investigator: Paulo Guilherme Hospital Santa Marcelina
Principal Investigator: Wagner Caiafa Santa Casa de Juiz de Fora
Principal Investigator: Antonio Scotton Centro MIneiro de Pesquisa - Juiz de Fora
Principal Investigator: Lindomar G. Oliveira Clínica de Ortopedia e Fraturas de Goiania
Principal Investigator: Antonio Carlos Ximenes CIP Pesquisas Médicas Ltda
Principal Investigator: Sonia Alvarenga Faculdade de Medicina ABC
Principal Investigator: Gilberto Brandão Clínica Perdizes
Principal Investigator: Luciana Teixeira IMA Brasil - Instituto de Medicina Avançada
Principal Investigator: Antonio Tarcísio Santa Casa de Misericórdia de Belo Horizonte
Principal Investigator: Carlos Roberto Galia Hospital de Clínicas de Porto Alegre
Principal Investigator: Mauro Hernandes Santa Casa de Votuporanga
Eurofarma Laboratorios S.A.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP