check_circleStudy Completed

Sinusitis

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

Both

Age

18 Years
  • 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
  • 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
January 2005 - March 2008
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Charlotte Eye, Ear, Nose, & Throat Associates, PACharlotte, 28210, United States
Completed
North Carolina Arthritis & Allergy Care Center, PARaleigh, 27609, United States
Completed
J. Lewis Research, Inc.Salt Lake City, 84109, United States
Completed
Allergy, Asthma & Sinus Center, SCGreenfield, 53228, United States
Completed
University Otolaryngology AssociatesRochester, 14618, United States
Completed
NEA ClinicJonesboro, 72401, United States
Completed
Pharmaceutical C-Trials, Inc.Houston, 77074, United States
Completed
Colorado Otolaryngology AssociatesColorado Springs, 80909, United States
Completed
SARC Research CenterFresno, 93720, United States
Completed
Internal Medicine Associates of South FloridaNorth Miami Beach, 33179, United States
Completed
Bellingham Asthma, Allergy & Immunology ClinicBellingham, 98225, United States
Completed
New Horizon Clinical ResearchCincinnati, 45241, United States
Completed
Digestive and Liver Disease SpecialistsGarden Grove, 92840, United States
Completed
Commonwealth Ear, Nose & ThroatLouisville, 40207, United States
Completed
ProMed PhysiciansPortage, 49024, United States
Completed
Alpha Clinical Research, LLCClarksville, 37043, United States
Terminated
Office of Dr. Chetan Shah, MDLawrenceville, 08698, United States
Completed
Family Medical AssociatesLevittown, 19056, United States
Terminated
Southeastern Ear, Nose, Throat Sinus CenterPembroke Pines, 33024, United States
Terminated
Bellam Medical ClinicDunnellon, 34432, United States
Completed
Allergy Medical Group of the North AreaRoseville, 95678, United States
Completed
J & S Studies, Inc.College Station, 77845, United States
Completed
Austin Ear, Nose and Throat ClinicAustin, 78705, United States
Completed
Children's Hospital of Orange CountyOrange, 92868, United States
Completed
Capstone Clinical Trials, Inc.Birmingham, 35209, United States
Completed
Clinical Research Center of CaliforniaSan Diego, 92106, United States
Completed
Eastern ResearchHialeah, 33013, United States
Completed
Clinical Research Center of CaliforniaWarner 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 MedicineLivonia, 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 CenterBridgeport, 06606, United States
Completed
Community Medical ProvidersFresno, 93710, United States
Completed
Pearl Clinical ResearchNorristown, 19401, United States
Completed
Dayton Clinical ResearchDayton, 45406, United States
Completed
Clinical Research Solutions, Inc.Atlanta, 30310, United States
Completed
San Antonio Ear, Nose & Throat ResearchSan Antonio, 78229, United States
Completed
Corona Research Consultants, Inc.El Paso, 79904, United States
Completed
Rappahannock Research CenterTappahannock, 22560, United States
Completed
Office of Dr. Marc H. Routman, MDBirmingham, 35209, United States
Completed
Coastal Medical Research Group, Inc.San Luis Obispo, 93405, United States
Completed
Central Jersey Health Care Associates, LLCElizabeth, 07202-3672, United States
Completed
Williamette Valley Clinical StudiesEugene, 97404, United States
Terminated
Associated Otolaryngologists of PennsylvaniaPalmyra, 17078, United States
Completed
ENT CareSomerville, 08876, United States
Completed
Broward Head, Neck, and Facial Plastic SurgeryPlantation, 33324, United States
Terminated
Henry Ford Health SystemDetroit, 48202, United States
Terminated
Teton Research, LLCLittle Rock, 72205, United States
Terminated
Mercury Street MedicalButte, 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 treatment
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    Safety Issue:
    No

Secondary Outcome

  • Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach
    date_rangeTime Frame:
    Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)
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    Safety Issue:
    No
  • Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach
    date_rangeTime Frame:
    Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Subjects With Clinical Improvement During Therapy
    date_rangeTime Frame:
    Day 3 of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up
    date_rangeTime Frame:
    Day 12 to 26 after end of treatment
    enhanced_encryption
    Safety Issue:
    No

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