Trials / Completed
CompletedNCT00492024
BAY12-8039: 5 Days for Sinusitis vs Placebo
Prospective, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg QD for 5 Days Versus Placebo in the Treatment of Acute Bacterial Sinusitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 374 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Moxifloxacin (Avelox, BAY12-8039) | Moxifloxacin - 400 mg once a day for 5 days |
| DRUG | Placebo | Placebo - 380 mg Microcrystalline Cellulose |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2007-06-27
- Last updated
- 2013-11-26
- Results posted
- 2009-12-02
Locations
51 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00492024. Inclusion in this directory is not an endorsement.