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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00668304 |
This study evaluated the time to eliminate the infecting bacteria and time to resolution of key clinical symptoms of acute bacterial sinusitis
Condition | Intervention | Phase |
---|---|---|
Maxillary Sinusitis |
Drug: Avelox (Moxifloxacin, BAY12-8039) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Prospective, Multicenter, Open, Uncontrolled Trial to Evaluate the Time to Bacterial Eradication and Key Symptom Relief in the Treatment of Acute Bacterial Maxillary Sinusitis With Moxifloxacin 400 mg QD |
Enrollment: | 200 |
Study Start Date: | June 2004 |
Study Completion Date: | January 2005 |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental
n/a
|
Drug: Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin 400 mg once orally daily
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This study evaluated the time to bacteriological eradication of common pathogens during moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the time to resolution of key symptoms associated with sinusitis.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical diagnosis of acute sinusitis with signs and symptoms present for >7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:
The presence of 1 or more of the following on a radiographic paranasal sinus film (Waters' view) or limited CT scan:
The presence of at least one major and one minor symptom as defined in the list below:
Major Symptoms
Minor Symptoms
Exclusion Criteria:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | ( Bayer Healthcare AG, Therapeutic Area Head ) |
Study ID Numbers: | 100569, SPEED |
Study First Received: | April 25, 2008 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00668304 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; United States: Food and Drug Administration |
Sinusitis |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Moxifloxacin Maxillary Sinusitis Sinusitis |
Anti-Infective Agents Paranasal Sinus Diseases Therapeutic Uses Pharmacologic Actions Nose Diseases |