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

Official Title: “A Comparative, Multi-Center, Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications”

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

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.

Intervention(s) in this Clinical Trial

• Drug: cefdinir (Omnicef)
  • 2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml
• Drug: azithromycin
  • 2.5 ml of cherry flavored oral suspension 100 mg/5 ml

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Taste and smell acceptance and preference
  • Time Frame: 2 hours
    Safety Issue?: No

Secondary Measures

• Adverse events assessment
  • Time Frame: 72 hours with follow-up to a satisfactory conclusion
    Safety Issue?: Yes
• Concomitant Medications
  • Time Frame: 72 hours
    Safety Issue?: Yes
• Vital signs
  • Time Frame: 2 hours
    Safety Issue?: Yes
• Any clinically abnormal observations
  • Time Frame: 2 hours with follow-up to a satisfactory conclusion
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 8 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Abbott Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644774

Study ID Number: M02-568

ClinicalTrials.gov Identifier: NCT00644774

Health Authority: United States: Food and Drug Administration