Status:
COMPLETED
Efficacy of the Combination of Ibuprofen and Paracetamol in Acute Non-specific Low Back Pain
Lead Sponsor:
Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborating Sponsors:
TFS Trial Form Support
Conditions:
Low Back Pain
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
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...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2022
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT05222724
Start Date
December 1 2021
End Date
October 5 2022
Last Update
January 31 2023
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Università degli Studi della Campania "Luigi Vanvitelli"
Caserta, CE, Italy, 81100
2
Azienda Ospedaliera Universitaria Policlinico G.Rodolico
Catania, Italy, 95123
3
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy, 37126
4
In-Vivo sp z o. o.
Bydgoszcz, Poland, 85-048