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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

Tracking Information
First Submitted Date  ICMJE June 26, 2007
First Posted Date  ICMJE June 27, 2007
Results First Submitted Date  ICMJE March 19, 2009
Results First Posted Date  ICMJE December 2, 2009
Last Update Posted Date November 26, 2013
Study Start Date  ICMJE January 2005
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2007)
The clinical response at the Test of Cure visit in the Modified ITT population [ Time Frame: Clinical Cure at TOC (Day +1 to +3) ]
Change History Complete list of historical versions of study NCT00492024 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2010)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2007)
Time to clinical improvement of sinusitis symptoms; subject reported time to symptom improvement; time to return to normal activities, clinical reponse during therapy and long term follow up and safety [ Time Frame: Clinical Response at Dur Tx (Day 3-4), TOC or PD, and F/U (Day +17 to +21); SNOT-16 and AIA at all visits and daily during tx; adverse events incidence rate ]
Current Other Pre-specified Outcome Measures
 (submitted: November 8, 2012)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BAY12-8039: 5 Days for Sinusitis vs Placebo
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sinusitis
Intervention  ICMJE
  • Drug: Moxifloxacin (Avelox, BAY12-8039)
    Moxifloxacin - 400 mg once a day for 5 days
  • Drug: Placebo
    Placebo - 380 mg Microcrystalline Cellulose
Study Arms  ICMJE
  • Experimental: Moxifloxacin 400 mg
    Moxifloxacin 400mg once daily for 5 days
    Intervention: Drug: Moxifloxacin (Avelox, BAY12-8039)
  • Placebo Comparator: Placebo
    Matching placebo for 5 days
    Intervention: Drug: Placebo
Publications * Hadley JA, Mösges R, Desrosiers M, Haverstock D, van Veenhuyzen D, Herman-Gnjidic Z. Moxifloxacin five-day therapy versus placebo in acute bacterial rhinosinusitis. Laryngoscope. 2010 May;120(5):1057-62. doi: 10.1002/lary.20878.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2011)
374
Original Enrollment  ICMJE
 (submitted: June 26, 2007)
390
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00492024
Other Study ID Numbers  ICMJE 11566
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP