Status:

COMPLETED

A Pediatric Taste Test Study of Omnicef Versus Zithromax 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 of cefdinir (Omnicef) antibiotic suspension and azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.

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 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, 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.

Key Trial Info

Start Date :

January 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

157 Patients enrolled

Trial Details

Trial ID

NCT00644774

Start Date

January 1 2003

Last Update

March 27 2008

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Scottsdale, Arizona, United States, 85251

2

St. Petersburg, Florida, United States, 33710

3

Miamiville, Ohio, United States, 45147