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: Completed Phase 3 study, sponsored by Pfizer.
NCT00643292 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 902 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00643292 record still lists
NCT00643292 is an interventional study that assigns participants to a tested intervention. The registered 902 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which azithromycin SR is the first listed.
NCT00643292 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00643292's enrollment target sits among peer trials
902 349th of 2000 higher than 1,652 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05769777 · 901 participants · Phase 2
Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
- NCT02352116 · 900 participants · NA
Evaluation of Post-PACU Pain Management in Pediatric Surgery
- NCT02414347 · 900 participants
F 18 T807 Tau PET Imaging of Alzheimer's Disease
- NCT02670408 · 900 participants
Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia