CLINICAL TRIAL, DOUBLE-BLIND, RANDOMIZED, COMPARED WITH PLACEBO TO EVALUATE THE EFFICACY AND SAFETY OF HYDROXOCOBALAMIN (VITAMIN B12) 10,000 MCG + THIAMINE HYDROCHLORIDE (VITAMIN B1) 100 MG + PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) 50 MG (BEDOYECTA® TRI), COMBINATED WITH STANDARD OF CARE TREATMENT IN PATIENTS WITH CHRONIC LOW BACK PAIN.
- Conditions
- M545 Low back painLow back painM545
- Registration Number
- PER-040-21
- Lead Sponsor
- aboratorios Grossman S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- In enrollment
- Sex
- All
- Target Recruitment
- 131
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method se of the NRS-11 scale.<br> NAME OF THE RESULT: 30% reduction in baseline score (visit 0) to day 28 of treatment on the NSR-11 pain scale<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: From the beginning to day 28 of treatment.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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