跳至主要内容
临床试验/EUCTR2014-004002-15-Outside-EU/EEA
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

Sanofi0 个研究点目标入组 210 人2014年12月19日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Pharyngotonsillitis
发起方
Sanofi
入组人数
210
状态
进行中(未招募)
最后更新
11年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2014年12月19日
结束日期
待定
最后更新
11年前
研究类型
Interventional clinical trial of medicinal product
性别
All

研究者

发起方
Sanofi

入排标准

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

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

结局指标

主要结局

未指定

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