Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00643292 · ClinicalTrials.gov registry record · Phase 3

A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
902
Enrollment target

NCT00643292 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 902 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00643292, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
902 participants
Enrollment target

Study Summary

A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent or recurrent ear infections

Interventions

  • DRUG azithromycin SR
  • DRUG amoxicillin/clavulanate postassium (Augmentin ES-600)

Trial Details

FieldValue
Enrollment Target 902 participants
Start Date 2003-01
Est. Completion 2004-05
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT00643292

The ClinicalTrials.gov registry entry for NCT00643292 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 902 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which azithromycin SR is the first listed.

NCT00643292 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00643292 about?

NCT00643292 is a clinical study titled "A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections". A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent or recurrent ear infection...

What is the current status of trial NCT00643292?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 902 participants. The study started on 2003-01. Estimated completion is 2004-05.

What interventions are being tested in trial NCT00643292?

The interventions under investigation include: azithromycin SR (DRUG), amoxicillin/clavulanate postassium (Augmentin ES-600) (DRUG).

Who is sponsoring clinical trial NCT00643292?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

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

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.