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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Lumbago
• Intervention / Treatment: Drug: meloxicam - Movatec®; Drug: cyclobenzaprine - Miosan®; Drug: meloxicam/cyclobenzaprine hydrochloride

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

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • GO
    • Goiania, GO, Brazil
      • Clínica de Ortopedia e Fraturas de Goiânia
    • Goiânia -, GO, Brazil
      • CIP Pesquisas Médicas Ltda
  • MG
    • Belo Horizonte, MG, Brazil
      • Santa Casa de Misericórdia de Belo Horizonte
    • Juiz de Fora, MG, Brazil
      • Santa Casa de Juíz de Fora
  • RS
    • Porto Alegre, RS, Brazil
      • Hospital de Clinicas de Porto Alegre
  • SP
    • Santo Andre,, SP, Brazil
      • Faculdade de Medicina ABC
    • São Paulo, SP, Brazil
      • Clinica de Ortopedia e Fisiatria Perdizes
    • São Paulo, SP, Brazil
      • Hospital Santa Marcelina
    • São Paulo, SP, Brazil
      • IMA Brasil
    • Votuporanga, SP, Brazil
      • Santa Casa de Votuporanga
  • São Paulo
    • São José Rio Preto, São Paulo, Brazil
      • Hospital de Base

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, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.
• Investigators: 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 Juíz de Fora; Principal Investigator: Antonio Scotton, Centro MIneiro de Pesquisa - Juiz de Fora; Principal Investigator: Lindomar G. Oliveira, Clínica de Ortopedia e Fraturas de Goiânia; 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 Clinicas de Porto Alegre; Principal Investigator: Mauro Hernandes, Santa Casa de Votuporanga

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 24, 2012
• First Submitted That Met QC Criteria: April 26, 2012
• First Posted (Estimate): April 30, 2012

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: April 29, 2016
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; 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; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Cyclooxygenase 2 Inhibitors; Neuromuscular Agents; Adrenergic Uptake Inhibitors; Muscle Relaxants, Central; Amitriptyline; Meloxicam; Cyclobenzaprine
• Other Study ID Numbers: EF 127