Status:

COMPLETED

Pediatric Taste Test Study of Cefdinir (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 was designed to determine if Omnicef or am...

Detailed Description

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.

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, 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 :

158 Patients enrolled

Trial Details

Trial ID

NCT00644891

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