CClinicalTrials.gg
CompletedNCT00644774Updated Mar 27, 2008

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

A Phase 4 interventional study of cefdinir (Omnicef) and azithromycin in Healthy, sponsored by Abbott. Completed at 3 sites in United States. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-03-27.

Sponsored by Abbott · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
157
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • pediatric taste test
  • antibiotic taste test
  • cefdinir
  • azithromycin
03

In context

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
157 participants (actual)

Study arms

  • Active comparator
    1

    Drug: cefdinir (Omnicef)

  • Active comparator
    2

    Drug: azithromycin

Interventions

  • Drugcefdinir (Omnicef)

    2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml

    Also known as: ABT-198, Omnicef, cefdinir

  • Drugazithromycin

    2.5 ml of cherry flavored oral suspension 100 mg/5 ml

    Also known as: Zithromax

06

What researchers measure

Primary outcomes

  1. Taste and smell acceptance and preference

    Time frame: 2 hours

Secondary outcomes

  1. Adverse events assessment

    Time frame: 72 hours with follow-up to a satisfactory conclusion

  2. Concomitant Medications

    Time frame: 72 hours

  3. Vital signs

    Time frame: 2 hours

  4. Any clinically abnormal observations

    Time frame: 2 hours with follow-up to a satisfactory conclusion

07

Study locations

3 sites
  • Scottsdale, Arizona 85251, United States
  • St. Petersburg, Florida 33710, United States
  • Miamiville, Ohio 45147, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00644774
Lead sponsor
Abbott
First posted
Mar 27, 2008
Start date
Jan 2003
Primary completion
Jan 2003
Last update
Mar 27, 2008
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion