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Completed Phase 4 Interventional

A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

ClinicalTrials.gov ID: NCT00644943

Public ClinicalTrials.gov record NCT00644943. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 8:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.

Study identification

NCT ID
NCT00644943
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Abbott
Industry
Enrollment
425 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Months to 6 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2003 (Type not available)
Primary completion
Apr 2003 (Actual)
Completion
Not listed
Last update posted
Mar 27, 2008

Started 2003

United States locations

U.S. sites
32
U.S. states
19
U.S. cities
31
Facility City State ZIP Site status
Not listed Birmingham Alabama 35211 —
Not listed Montgomery Alabama 36116 —
Not listed Ozark Alabama 36360 —
Not listed Mesa Arizona 85201 —
Not listed Scottsdale Arizona 85251 —
Not listed Little Rock Arkansas 72211 —
Not listed Clovis California 93612 —
Not listed Fresno California 93270 —
Not listed Longmont Colorado 80501 —
Not listed Fairfield Connecticut 06430 —
Not listed Marietta Georgia 30062 —
Not listed Stone Mountain Georgia 30087 —
Not listed Bardstown Kentucky 40004 —
Not listed Louisville Kentucky 40207 —
Not listed Owensboro Kentucky 42301 —
Not listed Ruston Louisiana 71270 —
Not listed Shreveport Louisiana 71105 —
Not listed Kalamazoo Michigan 49008 —
Not listed Richland Michigan 49083 —
Not listed Omaha Nebraska 68178 —
Not listed Las Vegas Nevada 89104 —
Not listed Columbus Ohio 43205 —
Not listed Medford Oregon 97504 —
Not listed Pittsburgh Pennsylvania 15241 —
Not listed Sellersville Pennsylvania 18960 —
Not listed Charleston South Carolina 29403 —
Not listed Austin Texas 78758 —
Not listed Lake Jackson Texas 77566 —
Not listed Salt Lake City Utah 84109 —
Not listed Salt Lake City Utah 84121 —
Not listed West Jordan Utah 84084 —
Not listed Vienna Virginia 22180 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00644943, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 27, 2008 · Synced Oct 17, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00644943 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →