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

Acute Lumbago Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01587508
• Other study ID #: EF 127
• Status: Withdrawn
• Phase: Phase 3
• First received: April 24, 2012
• Last updated: April 29, 2016
• Start date: May 2013
• Est. completion date: May 2013

Study information

• Verified date: April 2012
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lumbago
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Santa Casa de Misericórdia de Belo Horizonte	Belo Horizonte	MG
Brazil	Clínica de Ortopedia e Fraturas de Goiânia	Goiania	GO
Brazil	CIP Pesquisas Médicas Ltda	Goiânia -	GO
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	Hospítal de Base	São José Rio Preto	São Paulo
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

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes