EUCTR2014-004002-15-Outside-EU/EEA进行中（未招募）不适用
ocal, Phase IV, Multicenter, Double-blind, Randomized, Parallel, With Two Treatment Arms, Placebo-controlled Study to Evaluate the Reduction of Inflammatory Symptoms in the Treatment of Bacterial Pharyngitis With Ketoprofen and Amoxicillin in Pediatric Patients - DROPS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 210
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
- •Indication for treatment with amoxicillin according to labeling and physician's clinical evaluation.
- •Quick-test positive for Streptococcus pyogenes.
- •Pain (swallowing), evaluated by Wong Baker Faces Pain scale with at least grade 3.
- •Presence of at least two of the follow symptoms:
- •Hyperemia and edema evaluated with at least 2 crosses from 4;
- •Fever in the previous 48 hours;
- •Cervical adenomegaly;
- •Tonsilla with erythema or eythema and white exsudate
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 210
- •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
- •History of cardiovascular, gastrointestinal, metabolic or psychiatric conditions.
- •History and laboratorial confirmation of hematologic, hepatic or renal disorders.
- •Use of NSAIDs during the last 3 weeks and gastroesophageal reflux during the last 6 months.
- •Use of analgesic or anti inflammatory medication (except Paracetamol) in the previous 12 hours.
- •History of allergy or hypersensitivity to amoxicillin and/ or ketoprofen
研究者
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