Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago
Overview[ - collapse ][ - ]
| Purpose | 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 | Acute Lumbago |
| Intervention | Drug: meloxicam/cyclobenzaprine hydrochloride Drug: meloxicam - Movatec® Drug: cyclobenzaprine - Miosan® |
| Phase | Phase 3 |
| Sponsor | Eurofarma Laboratorios S.A. |
| Responsible Party | Eurofarma Laboratorios S.A. |
| ClinicalTrials.gov Identifier | NCT01587508 |
| First Received | April 24, 2012 |
| Last Updated | April 26, 2012 |
| Last verified | April 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 24, 2012 |
|---|---|
| Last Updated Date | April 26, 2012 |
| Start Date | November 2012 |
| Estimated Primary Completion Date | September 2013 |
| Current Primary Outcome Measures | Pain Reduction [Time Frame: Pain reduction 3 days after the administration of study drugs] [Designated as safety issue: No]Compare the treatment groups for the efficacy in pain reduction, 3 days after the administration of study drugs, when compared to the baseline assessment. |
| Current Secondary Outcome Measures | Frequency of rescue medication use [Time Frame: During study treatment, an expected average of 7days] [Designated as safety issue: Yes]Assessment of frequency of rescue medication use, as well as the proportion of patients during study treatment; |
Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
| 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 Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment |
| Condition | Acute Lumbago |
| Intervention | Drug: meloxicam/cyclobenzaprine hydrochloride two oral capsules a day during approximately 07 days Drug: meloxicam - Movatec® two oral tablet a day during approximately 07 days Drug: cyclobenzaprine - Miosan® two oral tablet a day during approximately 07 days |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 471 |
| Estimated Completion Date | September 2013 |
| Estimated Primary Completion Date | June 2013 |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Camille R. da Silva 55 11 41449681 camille.rodrigues@eurofarma.com.br |
| Location Countries | Brazil |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01587508 |
|---|---|
| Other Study ID Numbers | EF 127 |
| Has Data Monitoring Committee | No |
| Information Provided By | Eurofarma Laboratorios S.A. |
| Study Sponsor | Eurofarma Laboratorios S.A. |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Alceu Chueiri Hospital de Base de São José do Rio PretoPrincipal Investigator: Paulo Guilherme Hospital Santa MarcelinaPrincipal Investigator: Wagner Caiafa Santa Casa de Juiz de ForaPrincipal Investigator: Antonio Scotton Centro MIneiro de Pesquisa - Juiz de ForaPrincipal Investigator: Lindomar G. Oliveira Clínica de Ortopedia e Fraturas de GoianiaPrincipal Investigator: Antonio Carlos Ximenes CIP Pesquisas Médicas LtdaPrincipal Investigator: Sonia Alvarenga Faculdade de Medicina ABCPrincipal Investigator: Gilberto Brandão Clínica PerdizesPrincipal Investigator: Luciana Teixeira IMA Brasil - Instituto de Medicina AvançadaPrincipal Investigator: Antonio Tarcísio Santa Casa de Misericórdia de Belo HorizontePrincipal Investigator: Carlos Roberto Galia Hospital de Clínicas de Porto AlegrePrincipal Investigator: Mauro Hernandes Santa Casa de Votuporanga |
| Verification Date | April 2012 |
Locations[ + expand ][ + ]
| Clínica de Ortopedia e Fraturas de Goiânia | Goiania, GO, Brazil Contact: Rosariana | 55 62 9971-9509Principal Investigator: Lindomar G. Oliveira Not yet recruiting |
|---|---|
| CIP Pesquisas Médicas Ltda | Goiânia -, GO, Brazil Contact: Kelly | 55 62 3229-3280 | kellycristina_miranda@yahoo.com.brPrincipal Investigator: Antonio Ximenes Not yet recruiting |
| Santa Casa de Misericórdia de Belo Horizonte | Belo Horizonte, MG, Brazil Contact: Janiny | 55 31-9164-1543 | janiny.lage@santacasapesquisa.com.brPrincipal Investigator: Antonio Tarcísio Not yet recruiting |
| Santa Casa de Juíz de Fora | Juiz de Fora, MG, Brazil Contact: Nayara | 55 32 8811-4807 | nayarapedroso@yahoo.com.brPrincipal Investigator: Antonio Scotton Not yet recruiting |
| Hospital de Clínicas de Porto Alegre | Porto Alegre, RS, Brazil Contact: Laura | 55 51 3359 8307 | lauradbona@yahoo.com.brPrincipal Investigator: Carlos Galia Not yet recruiting |
| Faculdade de Medicina ABC | Santo Andre,, SP, Brazil Contact: Thabata Veiga | 55 11 7129-3608 | thabataveiga.pesquisa@yahoo.com.brPrincipal Investigator: Sonia Alvarenga Not yet recruiting |
| Hospital Santa Marcelina | São Paulo, SP, Brazil Contact: Isabel | 55 11 2217-3766 | isabelcpchsm@santamarcelina.orgPrincipal Investigator: Paulo G. Oliveira Not yet recruiting |
| Clinica de Ortopedia e Fisiatria Perdizes | São Paulo, SP, Brazil |
| IMA Brasil | São Paulo, SP, Brazil Contact: Daniela Fakih | 55 11 81624502 | lunappo@uol.com.brPrincipal Investigator: Luciana Teixeira Not yet recruiting |
| Santa Casa de Votuporanga | Votuporanga, SP, Brazil Principal Investigator: Mauro HenrandesNot yet recruiting |
| Hospítal de Base | São José Rio Preto, São Paulo, Brazil Contact: Ana Paula | 55 17 3201-5054 | anademore.cip@gmail.comPrincipal Investigator: Alceu Chueiri Not yet recruiting |