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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00644891
First received: March 22, 2008
Last updated: March 26, 2008
Last verified: March 2008

March 22, 2008
March 26, 2008
January 2003
January 2003   (final data collection date for primary outcome measure)
Taste/smell acceptance [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00644891 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications
A Comparative, Multi-Center, Pediatric Taste Test Study of Cefdinir (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 was 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 provided here; this study is a pediatric taste test.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Healthy
  • Drug: cefdinir (Omnicef)
    2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml
    Other Names:
    • ABT-198
    • Omnicef
    • cefdinir
  • Drug: amoxicillin
    2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 ml
    Other Name: amoxicillin
  • Active Comparator: 1
    Intervention: Drug: cefdinir (Omnicef)
  • Active Comparator: 2
    Intervention: Drug: amoxicillin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
Not Provided
January 2003   (final data collection date for primary outcome measure)

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.
Both
4 Years to 8 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00644891
M02-569
Not Provided
Angela M Nilius, Abbott
Abbott
Not Provided
Not Provided
Abbott
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP