M545 Low back pain Low back pain
Conditions
Interventions
Application of a Placebo injection twice a week for a minimum of 2 weeks and a maximum of 4 weeks. -
Application of an injectable of BEDOYECTA® TRI twice a week for a minimum of
Sponsors
Laboratorios Grossman S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 2. Moderate to severe chronic low back pain, defined as a score =4 and =8 rated on the NRS-11. 1. Clinical diagnosis of mechanical low back pain for at least 3 months, but not more than 6 months, confirmed (via CT or MRI obtained within 6 months prior to screening visit). 11. Pacientes que no usaron Bedoyecta® TRI en el pasado para tratar el dolor lumbar u otras afecciones patologicas. 3. Age greater than or equal to 18 and less than or equal to 60 years 4. Patient able to keep a diary during the study. 5. Patient with a body mass index (BMI) <30 kg/m2. 6. Patients with a history of using NSAIDs for pain management within the month prior to enrollment. 7. Patients who did not receive antidepressant and/or benzodiazepine medications for at least 60 days prior to study entry. 8. Patient is able to read and understand the language and content of study material, understand requirements for follow-up visits, is willing to provide information at scheduled evaluations, is willing and able to comply with study requirements. 9. The patient has under
Exclusion criteria
Exclusion criteria: 12. History of epilepsy. 13. History of polycythemia Vera. 14. Coagulation disorder. 15. Patients who have an unstable psychiatric condition. 16. Unexplained severe chest pain. 17. Any recent trauma that may raise the possibility of a fracture. 18. Fever and unexplained weight loss. 19. Bladder or bowel dysfunction. 20. History of carcinoma. 21. Progressive neurological deficit. 22. Gait disturbance, saddle anaesthesia, musculoskeletal related. 23. Radicular syndromes of idiopathic, metabolic, toxic, infectious, demyelinating or neoplastic etiology. 24. Patients with spondylolisthesis, spondylolysis, or ankylosing spondylitis. 25. 25. Patients with scoliosis of 15° or more. 26. Patients with inflammatory arthritis or severe degenerative process of the disc and facet. 27. Patients who have had prior spinal surgery, including rhizotomy, patients who are planning or have been recommended for spinal surgery. 28. Patients with known hypersensitivity to naproxen or celecoxib or diclofenac or any other ingredient of the investigational product. 29. Patient with known hypersensitivity to sulfonamide. 30. Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory agents (NSAIDs), including other specific cyclooxygenase-2 (COX-2) inhibitors. 31. Patients with any concomitant chronic disease or condition that may predispose them to a high probability of interfering with completion of study follow-up, such as peptic ulcer, liver disease, severe coronary artery disease, kidney disease, cancer, pregnancy, alcoholism, mental status or other clinically significant condition. 32. Patients with a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Use of the NRS-11 scale. NAME OF THE RESULT: 30% reduction in baseline score (visit 0) to day 28 of treatment on the NSR-11 pain scale PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From the beginning to day 28 of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| FRCe NAME OF THE RESULT: 6. Frequency of Adverse Events. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From start of treatment to day 35 (one week after last study drug administration) ;Use of the NRS-11 scale. NAME OF THE RESULT: 30% reduction in baseline score (visit 0) to day 28 of treatment on the NSR-11 pain scale PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From the beginning to day 28 of treatment. ;Use of the NRS-11 scale NAME OF THE RESULT: 1. Improved pain relief as change in NRS-11 score PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From baseline to day 15 and day 35. ;Using the Oswestry Low Back Pain Scale (ODI) NAME OF THE RESULT: 2. Improvement of functional disability as change in Oswestry Low Back Pain Disability Index (ODI) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: On days 0,7,14, 21 and 28. ;Clinical Evaluation. NAME OF THE RESULT: 3. Clinical improvement PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: On days 0 and 28 ;Use of the PGA scale. NAME OF THE RESULT: 4. PGA Patient Global Assessment PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: On days 0,7,14,21 and 28. ;Use of the Be | — |
Countries
Peru
Contacts
Public ContactRAUL FLORENTINO HERNAN YEPEZ
PERUVIAN CLINICAL RESEARCH S.A.C.
Outcome results
None listed