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BAY12-8039: 5 Days for Sinusitis vs Placebo

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sinusitis

Intervention: Moxifloxacin (Avelox, BAY12-8039) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))

Secondary outcome:

Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach

Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach

Percentage of Subjects With Clinical Improvement During Therapy

Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Birmingham, Alabama 35209, United States

Northport, Alabama 35476, United States

Jonesboro, Arkansas 72401, United States

Little Rock, Arkansas 72205, United States

Fresno, California 93720, United States

Fresno, California 93710, United States

Garden Grove, California 92840, United States

Orange, California 92868, United States

Roseville, California 95678, United States

San Diego, California 92106, United States

San Luis Obispo, California 93405, United States

Colorado Springs, Colorado 80909, United States

Bridgeport, Connecticut 06606, United States

Dunnellon, Florida 34432, United States

Hialeah, Florida 33013, United States

North Miami Beach, Florida 33179, United States

Pembroke Pines, Florida 33024, United States

Plantation, Florida 33324, United States

Atlanta, Georgia 30310, United States

Warner Robbins, Georgia 31093, United States

Warner Robins, Georgia 31088, United States

Louisville, Kentucky 40207, United States

Detroit, Michigan 48202, United States

Livonia, Michigan 48152, United States

Portage, Michigan 49024, United States

Butte, Montana 59701, United States

Elizabeth, New Jersey 07202-3672, United States

Lawrenceville, New Jersey 08698, United States

Somerville, New Jersey 08876, United States

Rochester, New York 14618, United States

Charlotte, North Carolina 28210, United States

Raleigh, North Carolina 27609, United States

Cincinnati, Ohio 45241, United States

Dayton, Ohio 45406, United States

Eugene, Oregon 97404, United States

Levittown, Pennsylvania 19056, United States

Norristown, Pennsylvania 19401, United States

Palmyra, Pennsylvania 17078, United States

Clarksville, Tennessee 37043, United States

Austin, Texas 78705, United States

College Station, Texas 77845, United States

El Paso, Texas 79904, United States

Houston, Texas 77074, United States

San Antonio, Texas 78229, United States

Salt Lake City, Utah 84109, United States

Salt Lake City, Utah 84121, United States

West Jordan, Utah 84084, United States

West Jordan, Utah 84088, United States

Tappahannock, Virginia 22560, United States

Bellingham, Washington 98225, United States

Greenfield, Wisconsin 53228, United States

Additional Information

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Starting date: January 2005
Last updated: October 31, 2013

Page last updated: August 23, 2015

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