Low Back Pain (LBP) MedDRA version: 21.1 Level: LLT Classification code 10024892 Term: Low back pain (without radiation) System Organ Class: 100000004859 MedDRA version: 21.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859
Conditions
Interventions
Trade Name: BRUFEN - 600 MG COMPRESSE RIVESTITE 30 COMPRESSE IN BLISTER
Product Name: Brufen 600 mg film-coated tablet
Product Code: [-]
Pharmaceutical Form: Tablet
Current Sponsor code: -
Concentrat
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 uncomplicated and localized acute low back pain or acute exacerbation of chronic low back pain (not radiating below the gluteal fold), with moderate/severe pain at baseline. Minimum VAS score = 40 mm at screening visit. 3. 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/Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption/Lactating and pregnant women/Clinically significant abnormalities on physical examination, vital signs or laboratory tests at Visit 0 which in the opinion of the Investigator could interfere with the study procedures or endpoints evaluation/Suspicious or confirmed COVID-19 infection at time of screening visit/History of cervical, thoracic, or lumbosacral pain for =75% of the time in the last year, or of any other LBP episode in the last 3 months that required pharmacological treatment with an opioid analgesic/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; history of hypersensitivity to aspirin or any other NSAIDs; suspicion of inflammatory, infective or neoplastic cause of pain; non- specific back symptoms related to abdominal, pelvic or thoracic pathology sensory and/or motor deficits in lower extremities; history of gastroduodenal ulcer or bleeding; history of severe cardiac, hepatic or renal insufficiency;current anticoagulant therapy; previous treatment with anticoagulants in the seven days before the screening visit;concomitant use of physical or alternative therapies to treat current episode of pain;local steroid injection for any reasons within previous 30 days; alcohol or drug-addition or abuse;cancer, not in remission or in remission less than 1 year; active influenza or other viral syndrome; immunosuppression; systematically unwell; unexplained significant weight loss; widespread neurological symptoms (including cauda equina syndrome) or any brain disease; ever suffered from any brain damage or have been in a coma; epilepsy or seizure; active or suspected oesophageal, gastric, pyloric channel, or duodenal ulceration, or bleeding in the last 30 days; blood-formation disturbance;renal and/or hepatic failure;acute hepatitis; acetylsalicylic acid-triggered asthma; history of asthma; glucose-6-phosphate dehydrogenase-deficient patients; glutathione deficiency, dehydration, chronic malnutrition; anaemia./Any other condition that, in the opinion of the Investigator, interferes with the study endpoints/procedures and does not justify the inclusion of the patient in the study/current use of full, regular, recommended doses of any topical or systemic analgesics, systemic corticosteroids, antidepressants, tranquilizers or muscle relaxants; and/or any medication that can alter the perception of pain (e.g., other drugs containing paracetamol, heparinoids, psychotropic agents, anti-H1 agents or glucocorticosteroids, etc.); use is forbidden for the entire trial duration/current use of the following medications (use is forbidden for the entire trial duration):narcotic analgesics;metoclopramide;propantheline;chloramphenicol; tacrolimus, ciclosporin, aminoglycosides and quinolone antibiotics;voriconazole and fluconazole (YP2C9 inhibitors);probenecid;zidovudine;co-trimoxazole;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the pain improvement in patients with uncomplicated non-specific acute low back pain after a 3-day treatment period with paracetamol/ibuprofen FDC compared to ibuprofen;Secondary Objective: A comparison between Group 1 and Group 2 will be performed on the following secondary objectives: •the intensity of LBP measured at baseline (Visit 0) and Visit 2 •the daily LBP assessment across the whole study duration •the degree of improvement in the patient’s mobility restriction, measured at Visits 0 and 1, 2 •the patient’s functional disability, measured at Visits 0 and 1, 2 •the patients’ global impression about the efficacy of the treatment, measured at Visit 1 and 2 •the clinical global impression about the efficacy of the treatment, at Visit 1 and 2 •safety and tolerability assessment.;Primary end point(s): The primary endpoint will be the area under the pain intensity difference-versus-time curve of LBP scores up to 3 days of treatment [SPID 0-3 days]. The pain intensity difference will be considered to be the difference in VAS pain intensity between one time-point and the baseline. The sum of the pain intensity differences (SPID) will be the sum of the average of two consecutive pain intensity differences multiplied by the time-interval between two time points.;Timepoint(s) of evaluation of this end point: after 3 days of medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in VAS score at baseline (Visit 0) and at the end of study (Visit 2) • Change from baseline up to the end of the study in VAS score, assessed at baseline (Visit 0) and Visit 2, and daily recorded in the patient diary during the whole home-stay period • Change from baseline up to the end of the study in the hand-to-floor distance assessed at Visits 0, 1 and 2, measured by a cm graduated bar • Change from baseline up to the end of the study in the in the degree of improvement in the functional disability, assessed at Visits 0 1 and 2, measured by the Oswestry Disability Index (ODI) • Change in the patients’ global impression at Visits 1 and 2, measured by the Patients’ Global Impression of Change (PGIC) scale • Change in the clinical global impression at Visits 1 and 2, measured by the Clinical Global Impression-Improvement (CGI-I) scale • Safety and tolerability assessment;Timepoint(s) of evaluation of this end point: from Visit 0 to Visit 2 | — |
Countries
Hungary, Italy, Poland
Contacts
Public ContactCarmelina Valerio
Angelini Pharma S.p.A.
Outcome results
None listed