CTIS2023-507510-27-00进行中（未招募）1 期
Randomized, single blind, non-inferiority study on the speed of action of lysin ibuprofen suspension vsibuprofen suspension in the treatment of acute pain in children (SAPed). - SAPed
Dicofarm S.p.A.0 个研究点目标入组 192 人开始时间: 2023年9月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 192
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
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •1. Male and female pediatric subjects from =4 =12 years old.. 2. Subjects admitted to ER with acute pain as a primary symptom or an accompanying symptom (sore throat, headache, ear pain, toothache, post-traumatic musculoskeletal pain). 3. Pain intensity =4, assessed with validated age-related scale of 10 points. 4. Written informed consent provided by parents/tutor, willing and able to understand the purpose of the study, including possible risks and side effects, and willing and able to comply, on their behalf and of the minor, with the study requirements. 5. Willing and able to give additional written informed consent by itself, in case of children and adolescents, in addition to parents/tutor. 6. Willing and able, in case of children and adolescents, to comply with the study requirements on their behalf.
排除标准
- •1. Subjects with hypersensitivity to ibuprofen, or to one of the components of IMP, or any other NSAID. 2. Chicken pox. 3. Dehydration. 4. Gastroenteritis. 5. Renal failure. 6. Thrombocytopenia, coagulopathies, and haemorrhagic diathesis. 7. A history of gastrointestinal bleeding or perforation related to previous drug treatments non-steroidal anti-inflammatory drugs (NSAIDs). 8. Peptic ulcer, active or recurrent gastrointestinal bleeding (two or more separate episodes occurring on ulceration or haemorrhage). 9. Severe heart failure (NYHA: class IV). 10. Severe liver failure. 11. Patients with hereditary fructose intolerance. 12. Wheat allergy. 13. Head and abdominal trauma. 14. The analgesic pain/ anti-inflammatory has already been administered at home (paracetamol in the previous 4 hours or ibuprofen in the previous 6 hours). 15. Subjects affected by delayed psychomotor development. 16. Vomiting after drug administration (drop out). 17. Participation in any other clinical study within the 3 months prior to the screening. 18. Pregnancy.
研究者
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