Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00644891

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: cefdinir (Omnicef) Drug: amoxicillin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject)
Official Title:	A Comparative, Multi-Center, Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Taste and Smell Disorders

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Cefdinir

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Taste/smell acceptance [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events assessment [ Time Frame: 72 hours with follow-up to a satisfactory conclusion ] [ Designated as safety issue: Yes ]
Concomitant Medications [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
Any clinically abnormal observations [ Time Frame: 2 hours with follow-up to a satisfactory conclusion ] [ Designated as safety issue: Yes ]

Enrollment:	158
Study Start Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: cefdinir (Omnicef) 2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml Other Names: ABT-198 Omnicef cefdinir
Active Comparator: 2	Drug: amoxicillin 2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 ml Other Name: amoxicillin

Detailed Description:

The Primary Purpose for the study is "Other". Per ClinicalTrials.gov, more information regarding the primary purpose is provided here; this study is a pediatric taste test.

Eligibility

Ages Eligible for Study:	4 Years to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644891

Locations

United States, Arizona

Scottsdale, Arizona, United States, 85251
United States, Florida

St. Petersburg, Florida, United States, 33710
United States, Ohio

Miamiville, Ohio, United States, 45147

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Angela M Nilius, Abbott
ClinicalTrials.gov Identifier:	NCT00644891 History of Changes
Other Study ID Numbers:	M02-569
Study First Received:	March 22, 2008
Last Updated:	March 26, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Pediatric taste test
Antibiotic taste test
cefdinir
amoxicillin

Additional relevant MeSH terms:

Amoxicillin
Anti-Bacterial Agents
Cefdinir
Cephalosporins

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012