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

Phase 3

Withdrawn

• Conditions: Acute Lumbago
• Interventions: Drug: cyclobenzaprine - Miosan®; Drug: meloxicam - Movatec®; Drug: meloxicam/cyclobenzaprine hydrochloride

• Registration Number: NCT01587508
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2012-04
• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Study Start: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cyclobenzaprine - Miosan®,	cyclobenzaprine - Miosan®	-
meloxicam - Movatec®	meloxicam - Movatec®	-
meloxicam/cyclobenzaprine hydrochloride	meloxicam/cyclobenzaprine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Pain Reduction	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

Name	Time	Method
Frequency of rescue medication use	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;

Trial Locations

Locations (11)

Santa Casa de Misericórdia de Belo Horizonte; 🇧🇷 Belo Horizonte, MG, Brazil

Clínica de Ortopedia e Fraturas de Goiânia; 🇧🇷 Goiania, GO, Brazil

Santa Casa de Votuporanga; 🇧🇷 Votuporanga, SP, Brazil

Santa Casa de Juíz de Fora; 🇧🇷 Juiz de Fora, MG, Brazil

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

CIP Pesquisas Médicas Ltda; 🇧🇷 Goiânia -, GO, Brazil

Faculdade de Medicina ABC; 🇧🇷 Santo Andre,, SP, Brazil

IMA Brasil; 🇧🇷 São Paulo, SP, Brazil

Clinica de Ortopedia e Fisiatria Perdizes; 🇧🇷 São Paulo, SP, Brazil

Hospital Santa Marcelina; 🇧🇷 São Paulo, SP, Brazil

Hospítal de Base; 🇧🇷 São José Rio Preto, São Paulo, Brazil