BAY12-8039 : 5 Days for Sinusitis vs Placebo - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00492024

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.

Condition	Intervention	Phase
Sinusitis	Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Percentage of Subjects With Clinical Improvement During Therapy [ Time Frame: Day 3 of treatment ] [ Designated as safety issue: No ]
Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up [ Time Frame: Day 12 to 26 after end of treatment ] [ Designated as safety issue: No ]

Enrollment:	374
Study Start Date:	January 2005
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Moxifloxacin 400 mg: Experimental Moxifloxacin 400mg once daily for 5 days	Drug: Avelox (Moxifloxacin, BAY12-8039) Moxifloxacin - 400 mg once a day for 5 days
Placebo: Placebo Comparator Matching placebo for 5 days	Drug: Placebo Placebo - 380 mg Microcrystalline Cellulose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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:
1. 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

2. 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492024

Show 52 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare Pharmaceuticals ( Therapeutic Area Head )
Study ID Numbers:	11566
Study First Received:	June 26, 2007
Results First Received:	March 19, 2009
Last Updated:	October 28, 2009
ClinicalTrials.gov Identifier:	NCT00492024 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Respiratory Tract Infection
Bacterial Sinusitis

Additional relevant MeSH terms:

Anti-Infective Agents
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Moxifloxacin

Paranasal Sinus Diseases
Therapeutic Uses
Sinusitis
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on February 08, 2010