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| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 22, 2008 |
| Last Updated Date | March 26, 2008 |
| Start Date ICMJE | January 2003 |
| Primary Completion Date | January 2003 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Taste/smell acceptance [ Time Frame: 2 hours ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00644891 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications |
| Official Title ICMJE | A Comparative, Multi-Center, Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications |
| 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. |
| 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. |
| Study Phase | Phase IV |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Other, Randomized, Single Blind (Subject), Crossover Assignment |
| Condition ICMJE | Healthy |
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 158 |
| Completion Date | |
| Primary Completion Date | January 2003 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 4 Years to 8 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00644891 |
| Responsible Party | Angela M Nilius, Abbott |
| Study ID Numbers ICMJE | M02-569 |
| Study Sponsor ICMJE | Abbott |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Abbott |
| Verification Date | March 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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