- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00645125
A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications
March 26, 2008 updated by: Abbott
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
154
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85251
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 mL
|
Active Comparator: 1
|
2.5 ml of strawberry cream flavored oral suspension 125 mg/5 mL
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Taste and smell acceptability assessment
Time Frame: 2 hours
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events assessment
Time Frame: 72 hours with follow-up to a satisfactory conclusion
|
72 hours with follow-up to a satisfactory conclusion
|
Vital signs
Time Frame: 2 hours
|
2 hours
|
Any clinically abnormal observations
Time Frame: 2 hours with follow-up to a satisfactory conclusion
|
2 hours with follow-up to a satisfactory conclusion
|
Concomitant medications
Time Frame: 72 hours
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
February 1, 2003
Study Registration Dates
First Submitted
March 22, 2008
First Submitted That Met QC Criteria
March 26, 2008
First Posted (Estimate)
March 27, 2008
Study Record Updates
Last Update Posted (Estimate)
March 27, 2008
Last Update Submitted That Met QC Criteria
March 26, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M02-567
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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