NCT00645125CompletedPhase 4
A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 154
- Primary Endpoint
- Taste and smell acceptability assessment
Study Overview
Brief Summary
To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It is designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.
Detailed Description
The Primary Purpose for the study is "Other". Per ClinicalTrials.gov, more information regarding the primary purpose is described here; the primary purpose for the study is to determine whether cefdinir possesses preferred taste and smell characteristics when compared to amoxicillin, a pediatric taste test.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 4 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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, could 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.
Arms & Interventions
1
Active Comparator
Intervention: cefdinir (Omnicef) (Drug)
2
Active Comparator
Intervention: amoxicillin (Drug)
Outcomes
Primary Outcomes
Taste and smell acceptability assessment
Time Frame: 2 hours
Secondary Outcomes
- 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)
Investigators
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