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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 902 participants |
| Start Date | 2003-01 |
| Est. Completion | 2004-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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