KCT0002888已完成未知
Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3 Clinical trial to assess the efficacy and safety of Propacetamol Compared to Dexibuprofen in patients with Acute upper respiratory tract infection
Yungjin Pharm0 个研究点目标入组 322 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 322
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 6(Month) 至 14(Year)（—）
- 性别
- All
入选标准
- •Selection Criteria
- •Patients who meet the following criteria should be selected.
- •1) Children 6 months to 14 years old
- •2) fever due to cold (acute upper respiratory infection) (=38 ?)
- •3) The applicant or who has a written consent of his / her parent (legal representative)
排除标准
- •Exclusion criteria
- •Patients who meet the conditions described below are excluded from the study.
- •1) Those taking antipyretic drugs within 4 hours
- •2) Those who had a febrile crisis within the last 6 months
- •3) Patients with severe blood disorders
- •4) Those with a medical history of kidney, liver, lung, endocrine, hematology, and heart, but who are within 6 months of termination of treatment
- •5) Those with neurologic or CNS disorders
- •6) Diabetic patients, currently unregulated status
- •7) Those suspected of having respiratory diseases caused by lower respiratory tract infection
- •8) Patients who participated in other clinical trial drug studies within the previous 4 weeks
- •9) Severe hemolytic anemia patients
- •10) Patients undergoing maintenance therapy for bronchial asthma
- •11) Those with asthma, urticaria or allergic reactions to aspirin or NSAIDs
- •12) A person who is not suitable for participation in the clinical trial, for either physically and mentally, judged by the examiner
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