A Randomized, Multicenter, Comparative Study To Assess Tolerability Of A Single Oral 60 Mg/Kg Dose Of Zmax (Pediatric Concentration) Vs. Zmax (Adult Concentration) In Pediatric Patients With Acute Otitis Media

Pfizer11 个研究点分布在 7 个国家目标入组 120 人开始时间: 2006年8月最近更新: 2011年5月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Pfizer
入组人数: 120
试验地点: 11
主要终点: Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Assess tolerability of different dosing formulations (adult versus pediatric).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 3 Months 至 48 Months（Child）
性别: All
接受健康志愿者: 否

入选标准

•Have clinical signs/symptoms of AOM in at least 1 ear

排除标准

•Known or suspected hypersensitivity, or intolerance to azithromycin or other macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor
•Previously diagnosed disease(s) of immune function
•Treatment with any systemic (intravenous, intramuscular, oral) antibiotic for any indication within 7 days prior to enrollment

结局指标

主要结局

Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.

次要结局

Time-to-vomiting (in minutes) will be measured for all vomiting episodes that occur within the 60-minute observation period post-dosing on Day 1.
Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population.
Frequencies of occurrence, by day, of treatment-related vomiting.
Investigator and Sponsor assessment of clinical response.

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (11)

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