Trial Condition(s):
Sinusitis
BAY12-8039: 5 days for Sinusitis vs Placebo
Bayer Identifier:
11566
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Charlotte Eye, Ear, Nose, & Throat Associates, PA Charlotte, United States, 28210 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations North Carolina Arthritis & Allergy Care Center, PA Raleigh, United States, 27609 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations J. Lewis Research, Inc. Salt Lake City, United States, 84109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allergy, Asthma & Sinus Center, SC Greenfield, United States, 53228 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Otolaryngology Associates Rochester, United States, 14618 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NEA Clinic Jonesboro, United States, 72401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pharmaceutical C-Trials, Inc. Houston, United States, 77074 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Colorado Otolaryngology Associates Colorado Springs, United States, 80909 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SARC Research Center Fresno, United States, 93720 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Internal Medicine Associates of South Florida North Miami Beach, United States, 33179 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bellingham Asthma, Allergy & Immunology Clinic Bellingham, United States, 98225 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Horizon Clinical Research Cincinnati, United States, 45241 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Digestive and Liver Disease Specialists Garden Grove, United States, 92840 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Commonwealth Ear, Nose & Throat Louisville, United States, 40207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ProMed Physicians Portage, United States, 49024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Alpha Clinical Research, LLC Clarksville, United States, 37043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Chetan Shah, MD Lawrenceville, United States, 08698 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Family Medical Associates Levittown, United States, 19056 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southeastern Ear, Nose, Throat Sinus Center Pembroke Pines, United States, 33024 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bellam Medical Clinic Dunnellon, United States, 34432 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allergy Medical Group of the North Area Roseville, United States, 95678 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations J & S Studies, Inc. College Station, United States, 77845 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Austin Ear, Nose and Throat Clinic Austin, United States, 78705 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital of Orange County Orange, United States, 92868 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Capstone Clinical Trials, Inc. Birmingham, United States, 35209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Center of California San Diego, United States, 92106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eastern Research Hialeah, United States, 33013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Center of California Warner Robins, United States, 31088 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Center of Georgia, Inc. Warner Robbins, United States, 31093 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations J. Lewis Research, Inc. Salt Lake City, United States, 84121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations J. Lewis Research, Inc. West Jordan, United States, 84088 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Michigan Institute of Medicine Livonia, United States, 48152 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations J. Lewis Research, Inc. West Jordan, United States, 84084 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West Alabama Research, Inc. Northport, United States, 35476 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Connecticut Sinus Center Bridgeport, United States, 06606 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Community Medical Providers Fresno, United States, 93710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pearl Clinical Research Norristown, United States, 19401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dayton Clinical Research Dayton, United States, 45406 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Solutions, Inc. Atlanta, United States, 30310 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations San Antonio Ear, Nose & Throat Research San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Corona Research Consultants, Inc. El Paso, United States, 79904 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rappahannock Research Center Tappahannock, United States, 22560 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Marc H. Routman, MD Birmingham, United States, 35209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Coastal Medical Research Group, Inc. San Luis Obispo, United States, 93405 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Central Jersey Health Care Associates, LLC Elizabeth, United States, 07202-3672 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Williamette Valley Clinical Studies Eugene, United States, 97404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Associated Otolaryngologists of Pennsylvania Palmyra, United States, 17078 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ENT Care Somerville, United States, 08876 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Broward Head, Neck, and Facial Plastic Surgery Plantation, United States, 33324 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Henry Ford Health System Detroit, United States, 48202 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Teton Research, LLC Little Rock, United States, 72205 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mercury Street Medical Butte, United States, 59701 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))Timeframe: At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment
Secondary Outcome
- Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) ApproachTimeframe: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)
- Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF ApproachTimeframe: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)
- Percentage of Subjects With Clinical Improvement During TherapyTimeframe: Day 3 of treatment
- Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-UpTimeframe: Day 12 to 26 after end of treatment
Additional Information
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