A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: cefdinir (Omnicef) (Drug); azithromycin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Abbott
Summary
To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and
azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.
Clinical Details
Official title: A Comparative, Multi-Center, Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications
Study design: Other, Randomized, Single Blind (Subject), Crossover Assignment
Primary outcome: Taste and smell acceptance and preference
Secondary outcome: Adverse events assessmentConcomitant Medications Vital signs Any clinically abnormal observations
Detailed description:
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.
Eligibility
Minimum age: 4 Years.
Maximum age: 8 Years.
Gender(s): Both.
Criteria:
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, 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.
Locations and Contacts
Scottsdale, Arizona 85251, United States
St. Petersburg, Florida 33710, United States
Miamiville, Ohio 45147, United States
Additional Information
Starting date: January 2003
Last updated: March 26, 2008
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