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临床试验/PER-040-21
PER-040-21招募中3 期

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.

aboratorios Grossman S.A.0 个研究点目标入组 131 人开始时间: 2022年4月27日最近更新:
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适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
131
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •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

排除标准

  • •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

研究者

发起方
aboratorios Grossman S.A.

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