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Completed Phase 2Phase 3 Interventional

Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

ClinicalTrials.gov ID: NCT00645203

Public ClinicalTrials.gov record NCT00645203. 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, 5:25 AM EDT

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

Official title

An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media

Brief summary

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

To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.

Study identification

NCT ID
NCT00645203
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Abbott
Industry
Enrollment
447 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Months to 4 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
Jul 2002 (Type not available)
Primary completion
Apr 2003 (Actual)
Completion
Not listed
Last update posted
Mar 27, 2008

Started 2002

United States locations

U.S. sites
13
U.S. states
8
U.S. cities
12
Facility City State ZIP Site status
Not listed Scottsdale Arizona 85258 —
Not listed Clovis California 93611 —
Not listed Dinuba California 93618 —
Not listed Folsom California 95630 —
Not listed Denver Colorado 80218 —
Not listed Brooklyn New York 11203 —
Not listed Rochester New York 14618 —
Not listed Rochester New York 14620 —
Not listed Chapel Hill North Carolina 27514 —
Not listed Erie Pennsylvania 16508 —
Not listed Pittsburgh Pennsylvania 15213 —
Not listed Dallas Texas 75390-9035 —
Not listed Salt Lake City Utah 84113 —

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00645203, 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 NCT00645203 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →