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

Efficacy and Safety of the Combination of Ibuprofen and Paracetamol Versus Ibuprofen in Monotherapy in Acute Low Back Pain (LBP)

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.

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.