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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abbott
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefdinir; Cephalosporins

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.