efficacy of the combination of ibuprofen and paracetamol in acute non-specific low back pain

Conditions: Low Back Pain

Summary: the aim of the present study is to assess the efficacy and safety of paracetamol/ibuprofen fixed dose combination (fdc) compared to ibuprofen in patients with uncomplicated non-specific acute low back pain after a 3-day treatment period.

this is a phase iv, multicenter, international, open-label, parallel-group study. the study will be conducted at sites located in italy, poland and hungary. the sites will be outpatient facilities and hospitals. a total of 176 patients are planned to be included in the study this trial will be conducted in accordance with the study protocol, gcps, declaration of helsinki (including up-to-date versions) and applicable regulatory requirements. the present clinical trial aims to evaluate the efficacy and safety of the combination of 2 tablets of paracetamol 500 mg/ibuprofen 150 mg administered 3 times daily, in the management of patients with acute non-specific low back pain (lbp) condition.

Eligibility criteria:
inclusion criteria: * male and female patients of any ethnic origin between 18 and 64 years of age (limits included). * 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. * women of childbearing potential and women with no menses for a period \< 12 months must have a negative pregnancy test at visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the final visit/visit 2, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (iud) or intrauterine hormone-releasing system (ius) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. the following definitions will be considered: * woman of childbearing potential (wocbp): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. * a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. * patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent. exclusion criteria: * 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 low back pain 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 non-steroidal anti-inflammatory drugs; 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.

Keywords: low back pain ibuprofen paracetamol tachifene®