check_circleStudy Completed
Sinusitis
Bayer Identifier:
11566
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
BAY12-8039: 5 days for Sinusitis vs Placebo
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
374Trial Dates
January 2005 - March 2008Phase
Phase 3Could I Receive a placebo
YesProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Charlotte Eye, Ear, Nose, & Throat Associates, PA | Charlotte, 28210, United States |
Completed | North Carolina Arthritis & Allergy Care Center, PA | Raleigh, 27609, United States |
Completed | J. Lewis Research, Inc. | Salt Lake City, 84109, United States |
Completed | Allergy, Asthma & Sinus Center, SC | Greenfield, 53228, United States |
Completed | University Otolaryngology Associates | Rochester, 14618, United States |
Completed | NEA Clinic | Jonesboro, 72401, United States |
Completed | Pharmaceutical C-Trials, Inc. | Houston, 77074, United States |
Completed | Colorado Otolaryngology Associates | Colorado Springs, 80909, United States |
Completed | SARC Research Center | Fresno, 93720, United States |
Completed | Internal Medicine Associates of South Florida | North Miami Beach, 33179, United States |
Completed | Bellingham Asthma, Allergy & Immunology Clinic | Bellingham, 98225, United States |
Completed | New Horizon Clinical Research | Cincinnati, 45241, United States |
Completed | Digestive and Liver Disease Specialists | Garden Grove, 92840, United States |
Completed | Commonwealth Ear, Nose & Throat | Louisville, 40207, United States |
Completed | ProMed Physicians | Portage, 49024, United States |
Completed | Alpha Clinical Research, LLC | Clarksville, 37043, United States |
Terminated | Office of Dr. Chetan Shah, MD | Lawrenceville, 08698, United States |
Completed | Family Medical Associates | Levittown, 19056, United States |
Terminated | Southeastern Ear, Nose, Throat Sinus Center | Pembroke Pines, 33024, United States |
Terminated | Bellam Medical Clinic | Dunnellon, 34432, United States |
Completed | Allergy Medical Group of the North Area | Roseville, 95678, United States |
Completed | J & S Studies, Inc. | College Station, 77845, United States |
Completed | Austin Ear, Nose and Throat Clinic | Austin, 78705, United States |
Completed | Children's Hospital of Orange County | Orange, 92868, United States |
Completed | Capstone Clinical Trials, Inc. | Birmingham, 35209, United States |
Completed | Clinical Research Center of California | San Diego, 92106, United States |
Completed | Eastern Research | Hialeah, 33013, United States |
Completed | Clinical Research Center of California | Warner Robins, 31088, United States |
Completed | Clinical Research Center of Georgia, Inc. | Warner Robbins, 31093, United States |
Completed | J. Lewis Research, Inc. | Salt Lake City, 84121, United States |
Completed | J. Lewis Research, Inc. | West Jordan, 84088, United States |
Completed | Michigan Institute of Medicine | Livonia, 48152, United States |
Completed | J. Lewis Research, Inc. | West Jordan, 84084, United States |
Completed | West Alabama Research, Inc. | Northport, 35476, United States |
Completed | Connecticut Sinus Center | Bridgeport, 06606, United States |
Completed | Community Medical Providers | Fresno, 93710, United States |
Completed | Pearl Clinical Research | Norristown, 19401, United States |
Completed | Dayton Clinical Research | Dayton, 45406, United States |
Completed | Clinical Research Solutions, Inc. | Atlanta, 30310, United States |
Completed | San Antonio Ear, Nose & Throat Research | San Antonio, 78229, United States |
Completed | Corona Research Consultants, Inc. | El Paso, 79904, United States |
Completed | Rappahannock Research Center | Tappahannock, 22560, United States |
Completed | Office of Dr. Marc H. Routman, MD | Birmingham, 35209, United States |
Completed | Coastal Medical Research Group, Inc. | San Luis Obispo, 93405, United States |
Completed | Central Jersey Health Care Associates, LLC | Elizabeth, 07202-3672, United States |
Completed | Williamette Valley Clinical Studies | Eugene, 97404, United States |
Terminated | Associated Otolaryngologists of Pennsylvania | Palmyra, 17078, United States |
Completed | ENT Care | Somerville, 08876, United States |
Completed | Broward Head, Neck, and Facial Plastic Surgery | Plantation, 33324, United States |
Terminated | Henry Ford Health System | Detroit, 48202, United States |
Terminated | Teton Research, LLC | Little Rock, 72205, United States |
Terminated | Mercury Street Medical | Butte, 59701, United States |
Primary Outcome
- Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))date_rangeTime Frame:At 'Test-of-Cure' (TOC), Day 1-5 after end of treatmentenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approachdate_rangeTime Frame:Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)enhanced_encryptionNoSafety Issue:
- Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approachdate_rangeTime Frame:Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)enhanced_encryptionNoSafety Issue:
- Percentage of Subjects With Clinical Improvement During Therapydate_rangeTime Frame:Day 3 of treatmentenhanced_encryptionNoSafety Issue:
- Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Update_rangeTime Frame:Day 12 to 26 after end of treatmentenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2