Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox (SPEED)
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ClinicalTrials.gov Identifier: NCT00668304 |
Recruitment Status
:
Completed
First Posted
: April 29, 2008
Last Update Posted
: December 19, 2014
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
Tracking Information | ||||
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First Submitted Date ICMJE | April 25, 2008 | |||
First Posted Date ICMJE | April 29, 2008 | |||
Last Update Posted Date | December 19, 2014 | |||
Study Start Date ICMJE | June 2004 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Time to bacteriological eradication in those who are microbiologically valid for S. pneumoniae, M. catarrhalis, and H. influenzae [ Time Frame: Days 1, 2, 3 of treatment ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00668304 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox | |||
Official Title ICMJE | Prospective, Multicenter, Open, Uncontrolled Trial to Evaluate the Time to Bacterial Eradication and Key Symptom Relief in the Treatment of Acute Bacterial Maxillary Sinusitis With Moxifloxacin 400 mg QD | |||
Brief Summary | This study evaluated the time to bacteriological eradication of common pathogens during moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the time to resolution of key symptoms associated with sinusitis. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Maxillary Sinusitis | |||
Intervention ICMJE | Drug: Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin 400 mg once orally daily |
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Study Arms | Experimental: Arm 1
Intervention: Drug: Avelox (Moxifloxacin, BAY12-8039) |
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
192 | |||
Original Actual Enrollment ICMJE |
200 | |||
Actual Study Completion Date | January 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00668304 | |||
Other Study ID Numbers ICMJE | 100569 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bayer | |||
Study Sponsor ICMJE | Bayer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Bayer | |||
Verification Date | December 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |