Trial Condition(s):

Sinusitis

BAY12-8039: 5 days for Sinusitis vs Placebo

Bayer Identifier:

11566

ClinicalTrials.gov Identifier:

NCT00492024

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
Subjects must meet all the following criteria at the time of enrollment: 
 - Age >/= 18 years
 - Clinical diagnosis of acute bacterial sinusitis with signs and symptoms present for = 7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:
 -- Radiographic Criteria: The presence of one or more of the following on a radiographic paranasal sinus film (Waters' view): - Evidence of air-fluid levels - Opacification
 -- Clinical Criteria: The presence of two major symptoms, or the presence of at least one major and one minor symptom as defined in the list below:
 --- Major symptoms: - Purulent anterior or posterior nasal discharge - Unilateral facial pain or malar tenderness
 --- Minor symptoms: - Frontal headache - Fever (oral = 38.0°C/100.4°F, tympanic = 38.5°C/101.2°F, axillary = 37.5°C/99.5°F) - Culture material obtained by sinus puncture; the aspirated specimen sent for Gram stain, quantitative culture and susceptibility testing prior to initiation of antimicrobial therapy
Exclusion Criteria
Subjects with one or more of the following criteria will not be eligible for this study:
 - History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subjects with recurrent acute sinusitis will be included)
 - History of sinus surgery (antral sinus puncture is not considered as a surgery)
 - Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
 - Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses

Trial Summary

Enrollment Goal
374
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
Locations

Charlotte Eye, Ear, Nose, & Throat Associates, PA

Charlotte, United States, 28210

Locations

North Carolina Arthritis & Allergy Care Center, PA

Raleigh, United States, 27609

Locations

J. Lewis Research, Inc.

Salt Lake City, United States, 84109

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Allergy, Asthma & Sinus Center, SC

Greenfield, United States, 53228

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University Otolaryngology Associates

Rochester, United States, 14618

Locations

NEA Clinic

Jonesboro, United States, 72401

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Pharmaceutical C-Trials, Inc.

Houston, United States, 77074

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Colorado Otolaryngology Associates

Colorado Springs, United States, 80909

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SARC Research Center

Fresno, United States, 93720

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Internal Medicine Associates of South Florida

North Miami Beach, United States, 33179

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Bellingham Asthma, Allergy & Immunology Clinic

Bellingham, United States, 98225

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New Horizon Clinical Research

Cincinnati, United States, 45241

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Digestive and Liver Disease Specialists

Garden Grove, United States, 92840

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Commonwealth Ear, Nose & Throat

Louisville, United States, 40207

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ProMed Physicians

Portage, United States, 49024

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Alpha Clinical Research, LLC

Clarksville, United States, 37043

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Office of Dr. Chetan Shah, MD

Lawrenceville, United States, 08698

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Family Medical Associates

Levittown, United States, 19056

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Southeastern Ear, Nose, Throat Sinus Center

Pembroke Pines, United States, 33024

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Bellam Medical Clinic

Dunnellon, United States, 34432

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Allergy Medical Group of the North Area

Roseville, United States, 95678

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J & S Studies, Inc.

College Station, United States, 77845

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Austin Ear, Nose and Throat Clinic

Austin, United States, 78705

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Children's Hospital of Orange County

Orange, United States, 92868

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Capstone Clinical Trials, Inc.

Birmingham, United States, 35209

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Clinical Research Center of California

San Diego, United States, 92106

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Eastern Research

Hialeah, United States, 33013

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Clinical Research Center of California

Warner Robins, United States, 31088

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Clinical Research Center of Georgia, Inc.

Warner Robbins, United States, 31093

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J. Lewis Research, Inc.

Salt Lake City, United States, 84121

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J. Lewis Research, Inc.

West Jordan, United States, 84088

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Michigan Institute of Medicine

Livonia, United States, 48152

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J. Lewis Research, Inc.

West Jordan, United States, 84084

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West Alabama Research, Inc.

Northport, United States, 35476

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Connecticut Sinus Center

Bridgeport, United States, 06606

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Community Medical Providers

Fresno, United States, 93710

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Pearl Clinical Research

Norristown, United States, 19401

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Dayton Clinical Research

Dayton, United States, 45406

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Clinical Research Solutions, Inc.

Atlanta, United States, 30310

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San Antonio Ear, Nose & Throat Research

San Antonio, United States, 78229

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Corona Research Consultants, Inc.

El Paso, United States, 79904

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Rappahannock Research Center

Tappahannock, United States, 22560

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Office of Dr. Marc H. Routman, MD

Birmingham, United States, 35209

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Coastal Medical Research Group, Inc.

San Luis Obispo, United States, 93405

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Central Jersey Health Care Associates, LLC

Elizabeth, United States, 07202-3672

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Williamette Valley Clinical Studies

Eugene, United States, 97404

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Associated Otolaryngologists of Pennsylvania

Palmyra, United States, 17078

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ENT Care

Somerville, United States, 08876

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Broward Head, Neck, and Facial Plastic Surgery

Plantation, United States, 33324

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Henry Ford Health System

Detroit, United States, 48202

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Teton Research, LLC

Little Rock, United States, 72205

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Mercury Street Medical

Butte, United States, 59701

Trial Design