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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 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.

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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

Sponsor

Abbott

181 total trials

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What the Registry Record Tells You About NCT00645112

The ClinicalTrials.gov registry entry for NCT00645112 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 357 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 363-participant average among 8 other Acute Otitis Media trials with a reported enrollment target. The listed sponsor is Abbott, which has 181 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.