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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 is a Phase 4 study that has completed, run by Abbott. The registered enrollment target is 425 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00644943
The ClinicalTrials.gov registry entry for NCT00644943 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 425 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott, which has 181 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which cefdinir (Omnicef) is the first listed.
NCT00644943 reports 0 study locations.
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.
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