EUCTR2020-005278-86-IT进行中（未招募）1 期
Efficacy and safety of the combination of ibuprofen and paracetamol versus ibuprofen in monotherapy in acute Low Back Pain (LBP) - Efficacia e sicurezza della combinazione di ibuprofene e paracetamolo versus ibuprofene in monoterap
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.0 个研究点目标入组 176 人开始时间: 2021年6月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 176
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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;
研究者
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