Status:
COMPLETED
A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications
Lead Sponsor:
Abbott
Conditions:
Healthy
Eligibility:
All Genders
4-8 years
Phase:
PHASE4
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 amo...
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 cefdin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00645125
Start Date
January 1 2003
Last Update
March 27 2008
Active Locations (1)
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1
Scottsdale, Arizona, United States, 85251