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NCT00644943 · ClinicalTrials.gov registry record · Phase 4
A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
A Phase 4 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 4
- Development phase
- 425
- Enrollment target
NCT00644943: Completed Phase 4 study, sponsored by Abbott.
NCT00644943 is a Phase 4 study that has completed, run by Abbott. The registered enrollment target is 425 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00644943, a Phase 4 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 425 participants
- Enrollment target
Study Summary
The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.
Interventions
- DRUG cefdinir (Omnicef)
- DRUG amoxicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2003-02 |
| Phase | Phase 4 |
What the finished NCT00644943 record still lists
NCT00644943 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which cefdinir (Omnicef) is the first listed.
NCT00644943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00644943 about?
NCT00644943 is a clinical study titled "A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media". The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with ...
What is the current status of trial NCT00644943?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 425 participants. The study started on 2003-02.
What interventions are being tested in trial NCT00644943?
The interventions under investigation include: cefdinir (Omnicef) (DRUG), amoxicillin (DRUG).
Who is sponsoring clinical trial NCT00644943?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00644943's enrollment target sits among peer trials
425 197th of 2000 higher than 1,802 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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