EUCTR2019-000647-27-IT进行中（未招募）1 期
Evaluation of efficacy and bioavailability of a new pediatric formulation based on ibuprofen lysinate vs ibuprofen in the management of pain in children - Efficacy and bioavailability of ibuprofen lysinate
Dicofarm S.p.A.0 个研究点目标入组 84 人开始时间: 2020年10月7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
- 84
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
- •Age between 4-12 years
- •Post-operative pain and pain on an inflammatory basis: mild (FPS-R: 2) or mild-moderate (FPS-R: from 4 to 6)
- •Understanding of the Italian language by parents or legal guardian
- •Written informed consent, signed by the parents or legal guardian
- •Consent of the child with age between 8-12 years
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hypersensitivity to ibuprofen, to any other NSAID or to any of the excipients of the product: Purified water, Microcrystalline cellulose, Sodium carboxymethyl cellulose, Sorbitol (E-420), Maltitol (E-965), Beta-cyclodextrin, Sodium saccharin,
- •Sucralose (E-955), Aroma of wild berries, Allura Red AC dye (E-129), Methyl para-hydroxybenzoate (E-218), Ethyl para-hydroxybenzoate (E-214), Propyl para-hydroxybenzoate (E-216)
- •Verified allergy to ibuprofen or or acetylsalicylic acid or other NSAIDs (attacks of asthma, acute rhinitis, urticaria or angioneurotic oedema)
- •Gastrointestinal haemorrhage or perforation related to previous treatments with NSAIDs
- •Peptic ulcer, active or recurrent gastrointestinal haemorrhage (two or more separate episodes)
- •Crohn's disease or active ulcerative colitis
- •Severe heart failure (NYHA class IV)
- •Renal failure (GFR <35mL / min, calculated with Schwartz formula, according to pRIFLE-Pediatric Risk, Injury, Failure, Loss, End Stage Renal Disease)
- •Acute liver failure (Pediatric Acute Liver Failure Registry, PALF):
- •- Acute onset liver failure (8 weeks from the onset of liver disease)
- •- Biochemical evidence of liver damage (elevation of ALT, AST and / or total and conjugated bilirubin)
- •- Incorrect coagulopathy from vitamin K (INR> = 1.5)
- •- Clinical evidence of encephalopathy
- •Chronic hepatic failure (starting with Pugh-Child Score Class A)
- •Haemorrhagic diathesis or coagulation disorders
- •Pregnancy
- •Cognitive delay
- •Lack of understanding of the Italian language by parents or legal guardian
研究者
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