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NCT00645112 · ClinicalTrials.gov registry record · Phase 4

A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

A Phase 4 study of Acute Otitis Media, sponsored by Abbott.

Completed
Registry status
Phase 4
Development phase
357
Enrollment target
20
Study locations

NCT00645112: Completed Phase 4 study of Acute Otitis Media, sponsored by Abbott.

NCT00645112 is a Phase 4 study of Acute Otitis Media that has completed, run by Abbott. The registered enrollment target is 357 participants, roughly in line with the 363-participant average among 8 other Acute Otitis Media trials with a reported enrollment target. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00645112, a Phase 4 study of Acute Otitis Media, has completed, sponsored by Abbott.

COMPLETED
Registry status
Phase 4
Development phase
357 participants
Enrollment target
20
Study locations

Study Summary

To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.

Conditions Studied

Acute Otitis Media

Interventions

  • DRUG azithromycin
  • DRUG cefdinir (Omnicef)

Study Locations (20)

Michigan

  • - Cadillac
  • - Kalamazoo
  • - Portage
  • - Richland

Alabama

  • - Columbiana
  • - Montgomery
  • - Ozark

Kentucky

  • - Bardstown
  • - Louisville
  • - Owensboro

California

  • - Fresno
  • - Fresno

Georgia

  • - Marietta
  • - Stone Mountain

Ohio

  • - Columbus
  • - Huber Heights

Pennsylvania

  • - Pittsburgh
  • - Reading

Iowa

  • - Dubuque

Trial Details

FieldValue
Enrollment Target 357 participants
Start Date 2003-11
Phase Phase 4
Abbott

181 total trials

What the finished NCT00645112 record still lists

NCT00645112 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 363-participant average among 8 other Acute Otitis Media trials with a reported enrollment target.

The record links to 1 condition, with Acute Otitis Media appearing as the primary indexed condition, and to 2 interventions - of which azithromycin is the first listed.

NCT00645112 names 20 study sites across 9 states, led by Michigan, Alabama, Kentucky.

Frequently Asked Questions

What is clinical trial NCT00645112 about?

NCT00645112 is a clinical study titled "A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media". To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.

What is the current status of trial NCT00645112?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 357 participants. The study started on 2003-11.

What conditions does trial NCT00645112 study?

This clinical trial studies the following conditions: Acute Otitis Media.

What interventions are being tested in trial NCT00645112?

The interventions under investigation include: azithromycin (DRUG), cefdinir (Omnicef) (DRUG).

Who is sponsoring clinical trial NCT00645112?

This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00645112 being conducted?

This trial has 20 study locations across Alabama, California, Georgia, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Acute Otitis Media

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00645112's enrollment target sits among peer trials

357 3rd of 8 higher than 6 of 8 other Acute Otitis Media trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Otitis Media trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00645112, the US trial registry maintained by the National Library of Medicine. NCT00645112 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.