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BAY12-8039: 5 Days for Sinusitis vs Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00492024
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : December 2, 2009
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sinusitis Drug: Moxifloxacin (Avelox, BAY12-8039) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Experimental: Moxifloxacin 400 mg
Moxifloxacin 400mg once daily for 5 days
Drug: Moxifloxacin (Avelox, BAY12-8039)
Moxifloxacin - 400 mg once a day for 5 days

Placebo Comparator: Placebo
Matching placebo for 5 days
Drug: Placebo
Placebo - 380 mg Microcrystalline Cellulose




Primary Outcome Measures :
  1. Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT)) [ Time Frame: At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment ]
    The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.


Secondary Outcome Measures :
  1. Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach [ Time Frame: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment) ]
    The Sino-Nasal Outcome Test (SNOT-16) was used to assess subject-reported time to symptom improvement. Improvement was defined as a decrease of at least 14 units on the test. This difference is the smallest difference that has been identified as beneficial to subjects.

  2. Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach [ Time Frame: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment) ]
    The Activity Impairment Assessment (AIA) questionnaire was used to assess activity impairment at baseline and time to return to normal activities. The AIA was administered prior to first dose, every 24 hours during treatment, and at the TOC visit. Improvement in the AIA total score was defined as a decrease of at least 3 units.

  3. Percentage of Subjects With Clinical Improvement During Therapy [ Time Frame: Day 3 of treatment ]
    A secondary efficacy variable was clinical response (CR) at the During Therapy visit at day 3 or 4 of treatment. CR was rated as improvement, cure, failure, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.

  4. Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up [ Time Frame: Day 12 to 26 after end of treatment ]
    A secondary efficacy variable was clinical response (CR) at the Follow-up visit 17-21 days following the start of treatment. CR was rated as continued cure, failure/relapse, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.


Other Outcome Measures:
  1. Percentage of Subjects With Clinical Cure (Per Protocol Population (PP)) [ Time Frame: At 'Test-of-Cure', Day 1-5 after end of treatment ]
    The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492024


Locations
Hide Hide 51 study locations
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United States, Alabama
Birmingham, Alabama, United States, 35209
Northport, Alabama, United States, 35476
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
United States, California
Fresno, California, United States, 93710
Fresno, California, United States, 93720
Garden Grove, California, United States, 92840
Orange, California, United States, 92868
Roseville, California, United States, 95678
San Diego, California, United States, 92106
San Luis Obispo, California, United States, 93405
United States, Colorado
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
Bridgeport, Connecticut, United States, 06606
United States, Florida
Dunnellon, Florida, United States, 34432
Hialeah, Florida, United States, 33013
North Miami Beach, Florida, United States, 33179
Pembroke Pines, Florida, United States, 33024
Plantation, Florida, United States, 33324
United States, Georgia
Atlanta, Georgia, United States, 30310
Warner Robbins, Georgia, United States, 31093
Warner Robins, Georgia, United States, 31088
United States, Kentucky
Louisville, Kentucky, United States, 40207
United States, Michigan
Detroit, Michigan, United States, 48202
Livonia, Michigan, United States, 48152
Portage, Michigan, United States, 49024
United States, Montana
Butte, Montana, United States, 59701
United States, New Jersey
Elizabeth, New Jersey, United States, 07202-3672
Lawrenceville, New Jersey, United States, 08698
Somerville, New Jersey, United States, 08876
United States, New York
Rochester, New York, United States, 14618
United States, North Carolina
Charlotte, North Carolina, United States, 28210
Raleigh, North Carolina, United States, 27609
United States, Ohio
Cincinnati, Ohio, United States, 45241
Dayton, Ohio, United States, 45406
United States, Oregon
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Levittown, Pennsylvania, United States, 19056
Norristown, Pennsylvania, United States, 19401
Palmyra, Pennsylvania, United States, 17078
United States, Tennessee
Clarksville, Tennessee, United States, 37043
United States, Texas
Austin, Texas, United States, 78705
College Station, Texas, United States, 77845
El Paso, Texas, United States, 79904
Houston, Texas, United States, 77074
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84109
Salt Lake City, Utah, United States, 84121
West Jordan, Utah, United States, 84084
West Jordan, Utah, United States, 84088
United States, Virginia
Tappahannock, Virginia, United States, 22560
United States, Washington
Bellingham, Washington, United States, 98225
United States, Wisconsin
Greenfield, Wisconsin, United States, 53228
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Publications of Results:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00492024    
Other Study ID Numbers: 11566
First Posted: June 27, 2007    Key Record Dates
Results First Posted: December 2, 2009
Last Update Posted: November 26, 2013
Last Verified: November 2013
Keywords provided by Bayer:
Respiratory Tract Infection
Bacterial Sinusitis
Additional relevant MeSH terms:
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Moxifloxacin
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs