Efficacy of the Combination of Ibuprofen and Paracetamol in Acute Non-specific Low Back Pain

Inclusion Criteria:

• Male and female patients of any ethnic origin between 18 and 64 years of age (limitsincluded).
• Patients with uncomplicated and localized acute low back pain or acute exacerbation ofchronic low back pain (not radiating below the gluteal fold), with moderate/severepain at baseline. Minimum VAS score ≥ 40 mm at screening visit.
• Women of childbearing potential and women with no menses for a period < 12 months musthave a negative pregnancy test at Visit 0 and have to agree not to start a pregnancyfrom the signature of the informed consent up to the Final Visit/Visit 2, using anappropriate birth control method such as combined oestrogen-progestin containinghormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonalcontraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) orIntrauterine hormone-releasing System (IUS) in combination with male condom, bilateraltubal occlusion, vasectomised partner, sexual abstinence. The following definitionswill be considered:
• Woman of childbearing potential (WOCBP): i.e., fertile, following menarche anduntil becoming post-menopausal, unless permanently sterile. Permanentsterilization methods include hysterectomy, bilateral salpingectomy and bilateraloophorectomy.
• A postmenopausal state is defined as no menses for 12 months without analternative medical cause.
• Patients legally capable of giving their consent to participate in the study andavailable to sign and date the written informed consent.

Exclusion Criteria:

• Known hypersensitivity or allergy to the active ingredients and/or to any component ofthe study medications.
• Patients with rare hereditary problems of galactose intolerance, total lactasedeficiency or glucose-galactose malabsorption
• Lactating and pregnant women.
• Clinically significant abnormalities on physical examination, vital signs orlaboratory tests at Visit 0 which in the opinion of the Investigator could interferewith 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 lastyear, or of any other Low Back Pain episode in the last 3 months that requiredpharmacological treatment with an opioid analgesic.
• Patients with:
• serious spinal pathology; spinal surgery in the year prior to screening orhistory of more than one spinal surgery; history of severe lumbar spinalstenosis; ankylosing spondylitis; lumbosciatalgia; herniated disc orradiculopathy; severe arthritis and osteoporosis; muscular diseases, such asmyositis, 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-steroidalanti-inflammatory drugs; suspicion of inflammatory, infective or neoplastic causeof pain; non- specific back symptoms related to abdominal, pelvic or thoracicpathology 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 screeningvisit;
• concomitant use of physical or alternative therapies to treat current episode ofpain;
• 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; systematicallyunwell; unexplained significant weight loss;
• widespread neurological symptoms (including cauda equina syndrome) or any braindisease; ever suffered from any brain damage or have been in a coma; epilepsy orseizure;
• active or suspected oesophageal, gastric, pyloric channel, or duodenalulceration, 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.