Efficacy and Safety of the Combination of Ibuprofen and Paracetamol Versus Ibuprofen in Monotherapy in Acute Low Back Pain (LBP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 11
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tachifene
paracetamol 500 mg/ibuprofen 150 mg FDC, film-coated tablets. Two tablets 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).
干预措施: Tachifene (Drug)
Brufen
ibuprofen 600 mg, film coated tablets. One tablet 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).
干预措施: Brufen (Drug)
结局指标
主要结局
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
时间窗: From Day 1 up to Day 3 (±1)
The pain intensity difference will be considered to be the difference in VAS pain intensity between one time-point and the baseline. The sum of the pain intensity differences (SPID) will be the sum of the average of two consecutive pain intensity differences multiplied by the time-interval between two time points.
次要结局
- Change from baseline up to the end of the study in the hand-to-floor distance(Day 0, Day 4 and Day 8 (±1))
- Change from baseline up to the end of the study in the in the degree of improvement in the functional disability(Day 0, Day 4 and Day 8 (±1))
- Change in Visual Analogue Scale 0-10 cm (100 mm)(Day 0 and Day 8 (±1))
- Change from baseline up to the end of the study in Visual Analogue Scale 0-10 cm (100 mm) score.(From Day 0 to Day 8 (±1))
- Monitoring the frequency of adverse events(8 (±1) days)
- Change in the patients' global impression(Day 4 and Day 8 (±1))
- Change in the clinical global impression(Day 4 and Day 8 (±1))