Acute non-specific Low Back Pain MedDRA version: 21.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Robaxisal compuesto - ATC 47.091
Product Name: Robaxisal compuesto - ATC 47.091
Product Code: [NA]
Pharmaceutical Form: Tablet
INN or Proposed INN: METOCARBAMOLO
CAS Number: 532-03-6
Curre
Sponsors
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients of any ethnic origin between 18 and 64 years of age (limits included). 2. Patients with current episode of acute (pain lasting less than 6 weeks) non-specific LBP, defined as pain and discomfort, localised below the costal margin and above the inferior gluteal folds, with or without leg pain, or acute exacerbation of chronic low back pain defined with a VAS score greater than or equal 40 mm. 3. Patients with signs and symptoms of muscle spasm of the lumbar region, as clinically diagnosed by the Investigator. 4. Women of childbearing potential and women with no menses for a period =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or allergy to the active ingredients and/or to any component of the study medications. 2. Lactating and pregnant women 3. Clinically significant abnormalities on physical examination and vital signs at Visit 0 which in the opinion of the Investigator could interfere with the study procedures or endpoints evaluation 4. Suspicious or confirmed COVID-19 infection at time of screening visit 5. History of cervical, thoracic, or lumbosacral pain for + o =75% of the time in the last year, or any other LBP episode in the last 3 months that required pharmacological treatment with an opioid analgesic 6. Patients with: • serious spinal pathology; spinal surgery in the year prior to screening or history of more than one spinal surgery; history of severe lumbar spinal stenosis; ankylosing spondylitis; lumbosciatalgia; herniated disc or radiculopathy; severe arthritis and osteoporosis; muscular diseases, such as myositis, poliomyelitis, muscular dystrophy and myotonia; fibromyalgia; myasthenia grave; fracture or recent history of violent trauma of the back; structural deformity of the back;• cancer, not in remission or in complete remission less than 1 year;• active influenza or other viral syndrome; immunosuppression; systematically unwell; unexplained significant weight loss;women with polymenorrhea, endometriosis, ovarian cysts, uterine fibroids;• widespread neurological symptoms or any brain disease; ever suffered from any brain damage or have been in a coma; epilepsy or seizures;• active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration, or bleeding in the last 30 days;• previous treatment with anticoagulants in the seven days before the screening visit;• renal and/or hepatic failure;• acute hepatitis;• cardiac or pulmonary diseases;• acetylsalicylic acid-triggered asthma;• glucose-6-phosphate dehydrogenase-deficient patients; glutathione deficiency, dehydration, chronic malnutrition; anemia. Any other condition that, in the opinion of the Investigator, interferes with the study end-points/procedures and does not justify the inclusion of the patient in the study. 7. Current use of full, regular, recommended doses of any skeletal muscle relaxants/non – opioid analgesics/anti-inflammatory/NSAIDs in the 6 hours prior to the screening visit. Use is forbidden for the entire trial duration. 8. Current use of full, regular, recommended doses of or any medication that can alter the perception of pain (e.g., opioids, heparinoids, psychotropic agents, anti-H1 agents or glucocorticosteroids, etc.), in the 24 hours prior to the screening visit. Use is forbidden for the entire trial duration. Chronic intake of small doses of acetylsalicylic acid, i.e., =162 mg/daily, taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons could be continued for the duration of the study. 9. current use of the following medications (use is forbidden for the entire trial duration):• systemic corticosteroids;• other drugs containing paracetamol;• central nervous system (CNS) depressants and stimulants, including barbiturates, anaesthetics, appetite suppressants, anticonvulsants and lamotrigine (with the exception of therapeutic doses of benzodiazepines used as hypnoinducers in patients stabilised for more than one month since the screening visit);anticholinergic drugs; psychotropic drugs; anti-cholinesterase drugs, pyridostigmine;• oral anticoagulants;• chloramphenicol; rifampicin; zidov
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the time to reach the complete relief from LBP, defined as a VAS score greater than or equal 5 mm at two consecutive assessments, starting from Day 1 up to Day7 (±1).;Secondary Objective: • Assessment of the degree of improvement of the intensity of LBP from Visit 0 to Visit 1 • Assessment of the degree of improvement of the intensity of LBP from Visit 0 to Final Visit • Assessment of the degree of improvement in the mobility restriction from Visit 0 to Visit 1 and Final Visit • Assessment of the degree of improvement in the functional disability from Visit 0 to Visit 1 and Final Visit • Assessment of the patients’ global impression at Visit 1 and Final Visit • Assessment of the clinical global impression – improvement at Visit 1 and Final Visit • Safety assessment;Primary end point(s): The primary endpoint will be the Time to complete relief of pain, defined as the time when the complete pain relief is reached. A Complete pain relief is defined as a VAS score greater than or equal 5 mm at two consecutive assessments starting from Day1 up to Day7 (±1).;Timepoint(s) of evaluation of this end point: Day 7 (±1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in the Oswestry Disability Index (ODI) score at Visits 0, 1 and Final Visit; Change in LBP intensity at Visit 0 and Visit 1, measured by VAS; Change in LBP intensity at Visit 0 and Final Visit, measured by VAS; Change in the degree of improvement in the hand-to-floor distance, at Visit 0, 1 and Final Visit, measured by a cm graduated bar; Change in the Patients’ Global Impression of Change (PGIC) scale score at Visit 1 and Final Visit; Change in the Clinical Global Impression-Improvement (CGI-I) scale score at Visit 1 and Final Visit; Safety evaluation by monitoring frequency of adverse events (AEs) and change from baseline in physical examination and vital signs;Timepoint(s) of evaluation of this end point: Day 4 (±1) e Day 7 (±1); Day 4 (± 1); Day 7 (±1); Day 4 (±1) e Day 7 (±1); Day 4 (±1) e Day 7 (±1); Day 4 (±1) e Day 7 (±1); Day 4 (±1) e Day 7 (±1) | — |
Countries
Italy
Contacts
Public ContactDr. Carmelina Valerio, Primary Care
Angelini Pharma S.p.A.
Outcome results
None listed