Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago
This study is not yet open for participant recruitment.
Verified April 2012 by Eurofarma Laboratorios S.A.
Sponsor:
Eurofarma Laboratorios S.A.
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01587508
First received: April 24, 2012
Last updated: April 26, 2012
Last verified: April 2012
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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 | Intervention | Phase |
|---|---|---|
|
Acute Lumbago |
Drug: meloxicam/cyclobenzaprine hydrochloride Drug: meloxicam - Movatec® Drug: cyclobenzaprine - Miosan® |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Eurofarma Laboratorios S.A.:
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.
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;
| Estimated Enrollment: | 471 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587508
Contacts
| Contact: Camille R. da Silva | 55 11 41449681 | camille.rodrigues@eurofarma.com.br |
Locations
| Brazil | |
| Clínica de Ortopedia e Fraturas de Goiânia | Not yet recruiting |
| Goiania, GO, Brazil | |
| Contact: Rosariana 55 62 9971-9509 | |
| Principal Investigator: Lindomar G. Oliveira | |
| CIP Pesquisas Médicas Ltda | Not yet recruiting |
| Goiânia -, GO, Brazil | |
| Contact: Kelly 55 62 3229-3280 kellycristina_miranda@yahoo.com.br | |
| Principal Investigator: Antonio Ximenes | |
| Santa Casa de Misericórdia de Belo Horizonte | Not yet recruiting |
| Belo Horizonte, MG, Brazil | |
| Contact: Janiny 55 31-9164-1543 janiny.lage@santacasapesquisa.com.br | |
| Principal Investigator: Antonio Tarcísio | |
| Santa Casa de Juíz de Fora | Not yet recruiting |
| Juiz de Fora, MG, Brazil | |
| Contact: Nayara 55 32 8811-4807 nayarapedroso@yahoo.com.br | |
| Principal Investigator: Antonio Scotton | |
| Hospital de Clínicas de Porto Alegre | Not yet recruiting |
| Porto Alegre, RS, Brazil | |
| Contact: Laura 55 51 3359 8307 lauradbona@yahoo.com.br | |
| Principal Investigator: Carlos Galia | |
| Faculdade de Medicina ABC | Not yet recruiting |
| Santo Andre,, SP, Brazil | |
| Contact: Thabata Veiga 55 11 7129-3608 thabataveiga.pesquisa@yahoo.com.br | |
| Principal Investigator: Sonia Alvarenga | |
| Hospital Santa Marcelina | Not yet recruiting |
| São Paulo, SP, Brazil | |
| Contact: Isabel 55 11 2217-3766 isabelcpchsm@santamarcelina.org | |
| Principal Investigator: Paulo G. Oliveira | |
| Clinica de Ortopedia e Fisiatria Perdizes | |
| São Paulo, SP, Brazil | |
| IMA Brasil | Not yet recruiting |
| São Paulo, SP, Brazil | |
| Contact: Daniela Fakih 55 11 81624502 lunappo@uol.com.br | |
| Principal Investigator: Luciana Teixeira | |
| Santa Casa de Votuporanga | Not yet recruiting |
| Votuporanga, SP, Brazil | |
| Principal Investigator: Mauro Henrandes | |
| Hospítal de Base | Not yet recruiting |
| São José Rio Preto, São Paulo, Brazil | |
| Contact: Ana Paula 55 17 3201-5054 anademore.cip@gmail.com | |
| Principal Investigator: Alceu Chueiri | |
Sponsors and Collaborators
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 Juiz de Fora |
| Principal Investigator: | Antonio Scotton | Centro MIneiro de Pesquisa - Juiz de Fora |
| Principal Investigator: | Lindomar G. Oliveira | Clínica de Ortopedia e Fraturas de Goiania |
| 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 Clínicas de Porto Alegre |
| Principal Investigator: | Mauro Hernandes | Santa Casa de Votuporanga |
More Information
No publications provided
| Responsible Party: | Eurofarma Laboratorios S.A. |
| ClinicalTrials.gov Identifier: | NCT01587508 History of Changes |
| Other Study ID Numbers: | EF 127 |
| Study First Received: | April 24, 2012 |
| Last Updated: | April 26, 2012 |
| Health Authority: | Brazil: Ethics Committee Brazil: National Health Surveillance Agency |
Additional relevant MeSH terms:
|
Low Back Pain Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Cyclobenzaprine Amitriptyline Meloxicam Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Muscle Relaxants, Central Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Tranquilizing Agents Central Nervous System Depressants Analgesics, Non-Narcotic Analgesics Sensory System Agents Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Anti-Inflammatory Agents, Non-Steroidal |
ClinicalTrials.gov processed this record on May 23, 2013