Clinical trial NCT01587508: Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Acute Lumbago
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Pain Reduction
timeFrame: Pain reduction 3 days after the administration of study drugs
Secondary outcomes:
measure: Frequency of rescue medication use
timeFrame: During study treatment, an expected average of 7days
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Clínica de Ortopedia e Fraturas de Goiânia
state: GO
city: Goiânia -
country: Brazil
facility: CIP Pesquisas Médicas Ltda
state: GO
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericórdia de Belo Horizonte
state: MG
city: Juiz de Fora
country: Brazil
facility: Santa Casa de Juíz de Fora
state: MG
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Santo Andre,
country: Brazil
facility: Faculdade de Medicina ABC
state: SP
city: São Paulo
country: Brazil
facility: Clinica de Ortopedia e Fisiatria Perdizes
state: SP
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
state: SP
city: São Paulo
country: Brazil
facility: IMA Brasil
state: SP
city: Votuporanga
country: Brazil
facility: Santa Casa de Votuporanga
state: SP
city: São José Rio Preto
country: Brazil
facility: Hospítal de Base
state: São Paulo
Study officials:
affiliation: Hospital de Base de São José do Rio Preto
name: Alceu Chueiri
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Santa Marcelina
name: Paulo Guilherme
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Casa de Juiz de Fora
name: Wagner Caiafa
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro MIneiro de Pesquisa - Juiz de Fora
name: Antonio Scotton
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica de Ortopedia e Fraturas de Goiania
name: Lindomar G. Oliveira
role: PRINCIPAL_INVESTIGATOR
affiliation: CIP Pesquisas Médicas Ltda
name: Antonio Carlos Ximenes
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade de Medicina ABC
name: Sonia Alvarenga
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Perdizes
name: Gilberto Brandão
role: PRINCIPAL_INVESTIGATOR
affiliation: IMA Brasil - Instituto de Medicina Avançada
name: Luciana Teixeira
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Casa de Misericórdia de Belo Horizonte
name: Antonio Tarcísio
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Carlos Roberto Galia
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Casa de Votuporanga
name: Mauro Hernandes
role: PRINCIPAL_INVESTIGATOR
References: