A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications

March 26, 2008 updated by: Abbott

A Comparative, Multi-Center, Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications

To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

157

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

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
    • Florida
      • St. Petersburg, Florida, United States, 33710
    • Ohio
      • Miamiville, Ohio, United States, 45147

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 months to 4 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, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, etc.).
  • History of allergic reaction to cefdinir, azithromycin, 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
Drug: azithromycin
2.5 ml of cherry flavored oral suspension 100 mg/5 ml
Other Names:
  • Zithromax
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Taste and smell acceptance and preference
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
Concomitant Medications
Time Frame: 72 hours
72 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

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)

January 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-568

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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