Clinical trial NCT05222724: Efficacy of the Combination of Ibuprofen and Paracetamol in Acute Non-specific Low Back Pain
Official title: Efficacy and Safety of the Combination of Ibuprofen and Paracetamol Versus Ibuprofen in Monotherapy in Acute Low Back Pain (LBP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: low back pain
ibuprofen
Paracetamol
Tachifene®
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Sponsor class: INDUSTRY
Collaborators: name: TFS Trial Form Support
First posted: 2022-02-03
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: The primary endpoint will be the area under the pain intensity difference-versus-time curve of Low Back Pain scores up to 3 days of treatment
timeFrame: From Day 1 up to Day 3 (±1)
Secondary outcomes:
measure: Change in Visual Analogue Scale 0-10 cm (100 mm)
timeFrame: Day 0 and Day 8 (±1)
measure: Change from baseline up to the end of the study in Visual Analogue Scale 0-10 cm (100 mm) score.
timeFrame: From Day 0 to Day 8 (±1)
measure: Change from baseline up to the end of the study in the hand-to-floor distance
timeFrame: Day 0, Day 4 and Day 8 (±1)
measure: Change from baseline up to the end of the study in the in the degree of improvement in the functional disability
timeFrame: Day 0, Day 4 and Day 8 (±1)
measure: Change in the patients' global impression
timeFrame: Day 4 and Day 8 (±1)
measure: Change in the clinical global impression
timeFrame: Day 4 and Day 8 (±1)
measure: Monitoring the frequency of adverse events
timeFrame: 8 (±1) days
Other outcomes:
Locations:
city: Caserta
country: Italy
facility: Università degli Studi della Campania "Luigi Vanvitelli"
state: CE
city: Catania
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico G.Rodolico
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
city: Bydgoszcz
country: Poland
facility: In-Vivo sp z o. o.
city: Bydgoszcz
country: Poland
facility: Przychodnia "Przy Szapitalu"
city: Lublin
country: Poland
facility: Zespół Porani Specjalistycznych Reumed Filia nr 1 Wallenroda
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Toruń
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne
city: Warsaw
country: Poland
facility: Centrum Medyczne AstiMed
city: Warsaw
country: Poland
facility: Centrum Medyczne PRATIA
city: Warsaw
country: Poland
facility: Centrum Medyczne Reuma Park
Study officials:
References: