NCT00644891已完成4 期
A Comparative, Multi-Center, Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin 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
- 158
- 主要终点
- Taste/smell acceptance
研究概览
简要总结
To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It was designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.
详细描述
The Primary Purpose for the study is "Other". Per ClinicalTrials.gov, more information regarding the primary purpose is provided 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, 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: amoxicillin (Drug)
结局指标
主要结局
Taste/smell acceptance
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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