Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comparative, Multi-Center, Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications

Conditions
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Healthy

Intervention / Treatment
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* Drug: cefdinir (Omnicef)
* Drug: amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: cefdinir (Omnicef)<br>* 2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml<br>* Other names: cefdinir;|
| Active Comparator: 2<br> | Drug: amoxicillin<br>* 2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste/smell acceptance |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric taste test, Antibiotic taste test, cefdinir, amoxicillin