Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications

Condition(s) targeted: Healthy

Intervention: cefdinir (Omnicef) (Drug); amoxicillin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Abbott

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 amoxicillin is preferred to the other with regard to taste or smell.

Official title: A Comparative, Multi-Center, Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications

Study design: Other, Randomized, Single Blind (Subject), Crossover Assignment

Primary outcome: Taste/smell acceptance

Secondary outcome:

Adverse events assessment

Concomitant Medications

Vital signs

Any clinically abnormal observations

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.

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, 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.

Scottsdale, Arizona 85251, United States

St. Petersburg, Florida 33710, United States

Miamiville, Ohio 45147, United States

Starting date: January 2003
Last updated: March 26, 2008