A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications

Abbott

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: cefdinir (Omnicef); Drug: azithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644774

M02-568

Details and patient eligibility

About

To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.

Full 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.

Enrollment: 157 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

157 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: cefdinir (Omnicef)

2

Active Comparator group

Treatment:

Drug: azithromycin