Trial Condition(s):

Sinusitis

BAY12-8039: 5 days for Sinusitis vs Placebo

Bayer Identifier:

11566

ClinicalTrials.gov Identifier:

NCT00492024

EudraCT 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
Status
LocationsStatus
Locations

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

Charlotte, United States, 28210

Status
Terminated
 
Locations

North Carolina Arthritis & Allergy Care Center, PA

Raleigh, United States, 27609

Status
Completed
 
Locations

J. Lewis Research, Inc.

Salt Lake City, United States, 84109

Status
Completed
 
Locations

Allergy, Asthma & Sinus Center, SC

Greenfield, United States, 53228

Status
Completed
 
Locations

University Otolaryngology Associates

Rochester, United States, 14618

Status
Completed
 
Locations

NEA Clinic

Jonesboro, United States, 72401

Status
Completed
 
Locations

Pharmaceutical C-Trials, Inc.

Houston, United States, 77074

Status
Completed
 
Locations

Colorado Otolaryngology Associates

Colorado Springs, United States, 80909

Status
Completed
 
Locations

SARC Research Center

Fresno, United States, 93720

Status
Completed
 
Locations

Internal Medicine Associates of South Florida

North Miami Beach, United States, 33179

Status
Completed
 
Locations

Bellingham Asthma, Allergy & Immunology Clinic

Bellingham, United States, 98225

Status
Completed
 
Locations

New Horizon Clinical Research

Cincinnati, United States, 45241

Status
Completed
 
Locations

Digestive and Liver Disease Specialists

Garden Grove, United States, 92840

Status
Completed
 
Locations

Commonwealth Ear, Nose & Throat

Louisville, United States, 40207

Status
Completed
 
Locations

ProMed Physicians

Portage, United States, 49024

Status
Completed
 
Locations

Alpha Clinical Research, LLC

Clarksville, United States, 37043

Status
Completed
 
Locations

Office of Dr. Chetan Shah, MD

Lawrenceville, United States, 08698

Status
Terminated
 
Locations

Family Medical Associates

Levittown, United States, 19056

Status
Completed
 
Locations

Southeastern Ear, Nose, Throat Sinus Center

Pembroke Pines, United States, 33024

Status
Terminated
 
Locations

Bellam Medical Clinic

Dunnellon, United States, 34432

Status
Terminated
 
Locations

Allergy Medical Group of the North Area

Roseville, United States, 95678

Status
Completed
 
Locations

J & S Studies, Inc.

College Station, United States, 77845

Status
Completed
 
Locations

Austin Ear, Nose and Throat Clinic

Austin, United States, 78705

Status
Completed
 
Locations

Children's Hospital of Orange County

Orange, United States, 92868

Status
Completed
 
Locations

Capstone Clinical Trials, Inc.

Birmingham, United States, 35209

Status
Completed
 
Locations

Clinical Research Center of California

San Diego, United States, 92106

Status
Completed
 
Locations

Eastern Research

Hialeah, United States, 33013

Status
Completed
 
Locations

Clinical Research Center of California

Warner Robins, United States, 31088

Status
Completed
 
Locations

Clinical Research Center of Georgia, Inc.

Warner Robbins, United States, 31093

Status
Completed
 
Locations

J. Lewis Research, Inc.

Salt Lake City, United States, 84121

Status
Completed
 
Locations

J. Lewis Research, Inc.

West Jordan, United States, 84088

Status
Completed
 
Locations

Michigan Institute of Medicine

Livonia, United States, 48152

Status
Completed
 
Locations

J. Lewis Research, Inc.

West Jordan, United States, 84084

Status
Completed
 
Locations

West Alabama Research, Inc.

Northport, United States, 35476

Status
Completed
 
Locations

Connecticut Sinus Center

Bridgeport, United States, 06606

Status
Completed
 
Locations

Community Medical Providers

Fresno, United States, 93710

Status
Completed
 
Locations

Pearl Clinical Research

Norristown, United States, 19401

Status
Completed
 
Locations

Dayton Clinical Research

Dayton, United States, 45406

Status
Completed
 
Locations

Clinical Research Solutions, Inc.

Atlanta, United States, 30310

Status
Completed
 
Locations

San Antonio Ear, Nose & Throat Research

San Antonio, United States, 78229

Status
Completed
 
Locations

Corona Research Consultants, Inc.

El Paso, United States, 79904

Status
Completed
 
Locations

Rappahannock Research Center

Tappahannock, United States, 22560

Status
Completed
 
Locations

Office of Dr. Marc H. Routman, MD

Birmingham, United States, 35209

Status
Completed
 
Locations

Coastal Medical Research Group, Inc.

San Luis Obispo, United States, 93405

Status
Completed
 
Locations

Central Jersey Health Care Associates, LLC

Elizabeth, United States, 07202-3672

Status
Completed
 
Locations

Williamette Valley Clinical Studies

Eugene, United States, 97404

Status
Completed
 
Locations

Associated Otolaryngologists of Pennsylvania

Palmyra, United States, 17078

Status
Terminated
 
Locations

ENT Care

Somerville, United States, 08876

Status
Completed
 
Locations

Broward Head, Neck, and Facial Plastic Surgery

Plantation, United States, 33324

Status
Completed
 
Locations

Henry Ford Health System

Detroit, United States, 48202

Status
Terminated
 
Locations

Teton Research, LLC

Little Rock, United States, 72205

Status
Terminated
 
Locations

Mercury Street Medical

Butte, United States, 59701

Status
Terminated
 

Trial Design