Efficacy and safety of the combination of ibuprofen and paracetamol versus ibuprofen in monotherapy in acute Low Back Pain (LBP)

Phase 1

Conditions: ow Back Pain (LBP)
MedDRA version: 21.1Level: LLTClassification code 10024892Term: Low back pain (without radiation)System Organ Class: 100000004859
MedDRA version: 21.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2020-005278-86-IT

Lead Sponsor: AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 176

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 < 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.
4.Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 176
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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;