Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)
NCT ID: NCT01128530
Last Updated: 2011-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
161 participants
INTERVENTIONAL
2010-06-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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JNJ-32729463
JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily
JNJ-32729463
250 mg tablet twice daily
linezolid placebo
1 placebo tablet, twice daily
linezolid
linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily
linezolid
600 mg tablet twice daily
JNJ-32729463 placebo
1 placebo tablet twice daily
Interventions
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JNJ-32729463
250 mg tablet twice daily
linezolid
600 mg tablet twice daily
JNJ-32729463 placebo
1 placebo tablet twice daily
linezolid placebo
1 placebo tablet, twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women of childbearing potential must agree to use an acceptable form of contraception
* Infection site offers ability to obtain a microbiological specimen
* Received only 1 dose of any potentially effective systemic antibiotic within 24 hours of beginning study treatment
Exclusion Criteria
* Female and pregnant or breastfeeding or may be pregnant
* Chronic or underlying skin condition surrounding the area of infection that may complicate the assessment of response (e.g. atopic dermatitis, eczema, or psoriasis)
* Subject has infections with a high cure rate after surgical incision alone after aggressive local skin care
* Subject has infection(s) suspected to be caused by Gram-negative rods, anaerobic bacteria or unusual pathogens
* Subject has an infection that is expected to require other antifungal, antimycobacterial, or antibacterial agents in addition to study medication
Other protocol-specific eligibility criteria may apply
18 Years
70 Years
ALL
No
Sponsors
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Furiex Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Furiex Pharmaceuticals, Inc
Locations
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Furiex Research Site
Anaheim, California, United States
Furiex Research Site
Buena Park, California, United States
Furiex Research Site
Chula Vista, California, United States
Furiex Research Site
Fountain Valley, California, United States
Furiex Research Site
La Mesa, California, United States
Furiex Research Site
Long Beach, California, United States
Furiex Research Site
Oceanside, California, United States
Furiex Research Site
Santa Ana, California, United States
Furiex Research Site
Fort Myers, Florida, United States
Furiex Research Site
Kissimmee, Florida, United States
Furiex Research Site
Saint Cloud, Florida, United States
Furiex Research Site
Columbus, Georgia, United States
Furiex Research Site
Savannah, Georgia, United States
Furiex Research Site
Idaho Falls, Idaho, United States
Furiex Research Site
Libertyville, Illinois, United States
Furiex Research Site
Baton Rouge, Louisiana, United States
Furiex Research Site
New Orleans, Louisiana, United States
Furiex Research Site
Sulphur, Louisiana, United States
Furiex Research Site
Detroit, Michigan, United States
Furiex Research Site
Keego Harbor, Michigan, United States
Furiex Research Site
Butte, Montana, United States
Furiex Research Site
Toledo, Ohio, United States
Furiex Research Site
Philadelphia, Pennsylvania, United States
Furiex Research Site
Houston, Texas, United States
Furiex Research Site
Houston, Texas, United States
Furiex Research Site
Sugar Land, Texas, United States
Furiex Research Site
Webster, Texas, United States
Countries
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Other Identifiers
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32729463CSI2001
Identifier Type: -
Identifier Source: org_study_id