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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: Completed Phase 3 study, sponsored by Pfizer.
NCT00643409 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 541 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00643409 record still lists
NCT00643409 is an interventional study that assigns participants to a tested intervention. The registered 541 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00643409 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00643409's enrollment target sits among peer trials
541 694th of 2000 higher than 1,307 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
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