A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications

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

To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It is designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.

The Primary Purpose for the study is "Other". Per ClinicalTrials.gov, more information regarding the primary purpose is described here; the primary purpose for the study is to determine whether cefdinir possesses preferred taste and smell characteristics when compared to amoxicillin, 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: amoxicillin
  • 2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 mL

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Taste and smell acceptability assessment
  • 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, could 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.

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/NCT00645125

Study ID Number: M02-567

ClinicalTrials.gov Identifier: NCT00645125

Health Authority: United States: Food and Drug Administration