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Trial record 20 of 46 for:    CYCLOBENZAPRINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01587508
Recruitment Status : Withdrawn (The comparator product was withdrawn from the brazilian market not being possible to conduct the design regarding initially planned.)
First Posted : April 30, 2012
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Lumbago Drug: meloxicam/cyclobenzaprine hydrochloride Drug: meloxicam - Movatec® Drug: cyclobenzaprine - Miosan® Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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 Start Date : May 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: meloxicam - Movatec® Drug: meloxicam - Movatec®
two oral tablet a day during approximately 07 days

Active Comparator: cyclobenzaprine - Miosan®, Drug: cyclobenzaprine - Miosan®
two oral tablet a day during approximately 07 days

Experimental: meloxicam/cyclobenzaprine hydrochloride Drug: meloxicam/cyclobenzaprine hydrochloride
two oral capsules a day during approximately 07 days




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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;



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587508


Locations
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Brazil
Clínica de Ortopedia e Fraturas de Goiânia
Goiania, GO, Brazil
CIP Pesquisas Médicas Ltda
Goiânia -, GO, Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, MG, Brazil
Santa Casa de Juíz de Fora
Juiz de Fora, MG, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil
Faculdade de Medicina ABC
Santo Andre,, SP, Brazil
Clinica de Ortopedia e Fisiatria Perdizes
São Paulo, SP, Brazil
Hospital Santa Marcelina
São Paulo, SP, Brazil
IMA Brasil
São Paulo, SP, Brazil
Santa Casa de Votuporanga
Votuporanga, SP, Brazil
Hospítal de Base
São José Rio Preto, São Paulo, Brazil
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
Investigators
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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

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Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01587508     History of Changes
Other Study ID Numbers: EF 127
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: April 2012
Additional relevant MeSH terms:
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Cyclobenzaprine
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Meloxicam
Amitriptyline
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators