Scottsdale, Arizona, 85251, United States
NCT Number: NCT00645125
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.
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Notify MeKey information
Conditions
Age range
4 year–8 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
cefdinir (Omnicef)
Drug2.5 ml of strawberry cream flavored oral suspension 125 mg/5 mL
Other names: ABT-198, Omnicef, cefdinir
Amoxicillin
Drug2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 mL
Primary outcomes
-
Taste and smell acceptability assessment
Time frame: 2 hours
Secondary outcomes
-
Adverse events assessment
Time frame: 72 hours with follow-up to a satisfactory conclusion
-
Concomitant medications
Time frame: 72 hours
-
Vital signs
Time frame: 2 hours
-
Any clinically abnormal observations
Time frame: 2 hours with follow-up to a satisfactory conclusion
Sponsors and collaborators
Lead sponsor
Abbott
Industry
Registry information
Important dates
- Study start
- 2003
- Primary completion
- 2003
- First posted
- Mar 27, 2008
- Registry last updated
- Mar 27, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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