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

NCT00644891 | Completed Phase 4

• 1 other identifier: M02-569
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Healthy

Keywords

Pediatric taste test; Antibiotic taste test; cefdinir; amoxicillin

Outcome Measures

Primary Outcomes (1)

• Taste/smell acceptance

  2 hours

Secondary Outcomes (4)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: cefdinir (Omnicef)

2

ACTIVE COMPARATOR

Drug: amoxicillin

Interventions

cefdinir (Omnicef) DRUG

2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml

Also known as: ABT-198, Omnicef, cefdinir

1

amoxicillin DRUG

2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 ml

2

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (3)

Unknown Facility

Scottsdale, Arizona, 85251, United States

Location

Unknown Facility

St. Petersburg, Florida, 33710, United States

Location

Unknown Facility

Miamiville, Ohio, 45147, United States

Location

MeSH Terms

Interventions

Cefdinir; Amoxicillin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ampicillin; Penicillin G; Penicillins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 22, 2008
• First Posted: March 27, 2008
• Study Start: January 1, 2003
• Primary Completion: January 1, 2003
• Last Updated: March 27, 2008

Record last verified: 2008-03

Locations

US (3)