BAY12-8039: 5 Days for Sinusitis vs Placebo
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Tracking Information | |||||
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First Received Date ICMJE | June 26, 2007 | ||||
Last Updated Date | March 20, 2012 | ||||
Start Date ICMJE | January 2005 | ||||
Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] 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. |
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Original Primary Outcome Measures ICMJE |
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 |
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Original Secondary Outcome Measures ICMJE |
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 Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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Condition ICMJE | Sinusitis | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 374 | ||||
Completion Date | March 2008 | ||||
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:
Exclusion Criteria: Subjects with one or more of the following criteria will not be eligible for this study:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00492024 | ||||
Other Study ID Numbers ICMJE | 11566 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Therapeutic Area Head, Bayer Healthcare Pharmaceuticals | ||||
Study Sponsor ICMJE | Bayer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Bayer | ||||
Verification Date | March 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |