NCT00644774已完成4 期
A Comparative, Multi-Center, Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 157
- 主要终点
- Taste and smell acceptance and preference
研究概览
简要总结
To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.
详细描述
The Primary Purpose for the study is "Other". Per ClinicalTrias.gov, more information regarding the primary purpose is described here; this study is a pediatric taste test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male child age 4 through 8 years in good general health.
- •Minimum weight of 16.3 kg (36 lb).
- •Willing to comply with appropriate instructions provided to complete the study.
- •Written informed consent from parent/legal guardian.
排除标准
- •Current medical condition, that in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, etc.).
- •History of allergic reaction to cefdinir, azithromycin, prescription (e.g. penicillins or cephalosporins) and/or OTC medications, and/or food products.
- •History of significant medical condition (e.g., GI disorders, hematological or bleeding disorders, renal or hepatic diseases).
- •Use of any oral medication, vitamins or herbal supplements within 6 hours prior to tasting.
- •Temperature > than 99.2°F. Participation in a clinical or marketing research study within the past 3 months.
- •Sibling of another subject on the study, or living in the same household as another subject that has participated in a clinical or marketing research study within the past 3 months.
- •Family member or close friend employed by an advertising agency, market research company, and/or a company that processes or manufacturers medical or health care products.
研究组 & 干预措施
1
Active Comparator
干预措施: cefdinir (Omnicef) (Drug)
2
Active Comparator
干预措施: azithromycin (Drug)
结局指标
主要结局
Taste and smell acceptance and preference
时间窗: 2 hours
次要结局
- Adverse events assessment(72 hours with follow-up to a satisfactory conclusion)
- Concomitant Medications(72 hours)
- Vital signs(2 hours)
- Any clinically abnormal observations(2 hours with follow-up to a satisfactory conclusion)
研究者
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