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NCT00643409 · ClinicalTrials.gov registry record · Phase 3
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 541
- Enrollment target
NCT00643409 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 541 participants.
The verdict
NCT00643409, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 541 participants
- Enrollment target
Study Summary
The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.
Interventions
- OTHER placebo
- DRUG levofloxacin
- DRUG azithromycin SR (Zithromax; compound: CP-62,993)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 541 participants |
| Start Date | 2003-01 |
| Est. Completion | 2004-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00643409
The ClinicalTrials.gov registry entry for NCT00643409 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 541 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 3 interventions - of which placebo is the first listed.
NCT00643409 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00643409 about?
NCT00643409 is a clinical study titled "A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults". The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both...
What is the current status of trial NCT00643409?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 541 participants. The study started on 2003-01. Estimated completion is 2004-02.
What interventions are being tested in trial NCT00643409?
The interventions under investigation include: placebo (OTHER), levofloxacin (DRUG), azithromycin SR (Zithromax; compound: CP-62,993) (DRUG).
Who is sponsoring clinical trial NCT00643409?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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