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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: cefdinir (Omnicef); Drug: azithromycin

• Registration Number: NCT00644774
• Lead Sponsor: Abbott

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2003-01
• Status Verified: 2008-03
• Study First Submitted: 2008-03-22
• Study First Submitted QC: 2008-03-26
• Last Update Submitted: 2008-03-26
• Study First Posted: 2008-03-27
• Last Update Posted: 2008-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	cefdinir (Omnicef)	-
2	azithromycin	-

Primary Outcome Measures

Name	Time	Method
Taste and smell acceptance and preference	2 hours

Secondary Outcome Measures

Name	Time	Method
Adverse events assessment	72 hours with follow-up to a satisfactory conclusion
Concomitant Medications	72 hours
Vital signs	2 hours
Any clinically abnormal observations	2 hours with follow-up to a satisfactory conclusion