EUCTR2020-005278-86-PL进行中（未招募）1 期
Efficacy and safety of the combination of ibuprofen and paracetamol versus ibuprofen in monotherapy inacute Low Back Pain (LBP)
Angelini Pharma S.p.A.0 个研究点目标入组 175 人开始时间: 2021年10月29日最近更新:
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
- 175
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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), progestinonly 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.
- •2. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- •3. Lactating and pregnant women.
- •4. 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.
- •5. Suspicious or confirmed COVID-19 infection at time of screening visit.
- •6. 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.
- •7. 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; serious 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 LBP treatment within previous 30 days •local steroid injection for any reasons within previous 15 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 dehydrogenasedeficient
- •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.
- •8. current use of full, regular, recommended doses of any skeletal
- •muscle relaxants/non – opioid analgesics/anti-inflammatory/NSAIDs in the 6 hours prior to the screening visit and/or any medication that can alter the perception of pain (e.g. opioids, heparinoids, psychotropic agents, systemic corticosteroids, anti-H1 agents, or
- •glucocorticosteroids, etc.), in the 24 hours prior to the screening visit.
- •Use is forbidden for the entire trial duration, with the exception of
- •therapeutic doses of benzodiazepines used as hypnoinducers in patients stabilised for more than one mon
研究者
相似试验
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)ow Back Pain (LBP)MedDRA version: 21.1Level: LLTClassification code 10024892Term: Low back pain (without radiation)System Organ Class: 100000004859MedDRA version: 21.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859EUCTR2020-005278-86-ITAZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.176
已完成
3 期
Investigating the effect of using ibuprofen and netonal drugs before root canal treatment on the pain after treatment in teeth with irreversible pulpitisPulpits.Diseases of oral cavity, salivary glands and jawsk00-k14IRCT20230313057710N2Esfahan University of Medical Sciences60
尚未招募
Unknown
Evaluation of efficacy of add-on oral ibuprofen in children with tuberculous meningitis aged 1 month - 18 yearsCTRI/2023/04/051721AIIMS Rishikesh
已完成
不适用
Ibuprofen and morphine for acute pain in sickle cell diseaseHaematological DisordersSickle-cell disordersSickle cell diseaseISRCTN97241637orth West London Hospitals NHS Trust (UK)320
进行中（未招募）
不适用
Study comparing ibuprofen and ibuprofen arginine in the control of spontaneous pain in patients with osteoarthritis and stabilized hypertension.EUCTR2011-003826-28-ITZAMBON S.p.A.