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NCT00492024 · ClinicalTrials.gov registry record · Phase 3
BAY12-8039: 5 Days for Sinusitis vs Placebo
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 374
- Enrollment target
NCT00492024: Completed Phase 3 study, sponsored by Bayer.
NCT00492024 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 374 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00492024, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 374 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study Avelox is considered an investigational drug. In this study Avelox will be compared to placebo.
Primary Outcome
The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.
Interventions
- DRUG Placebo
- DRUG Moxifloxacin (Avelox, BAY12-8039)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 374 participants |
| Start Date | 2005-01 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00492024 record still lists
NCT00492024 is an interventional study that assigns participants to a tested intervention. The registered 374 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 (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00492024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00492024 about?
NCT00492024 is a clinical study titled "BAY12-8039: 5 Days for Sinusitis vs Placebo". The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, t...
What is the current status of trial NCT00492024?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 374 participants. The study started on 2005-01. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00492024?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (Avelox, BAY12-8039) (DRUG).
Who is sponsoring clinical trial NCT00492024?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00492024's enrollment target sits among peer trials
374 991st of 2000 higher than 1,010 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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