Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain
NCT ID: NCT01043263
Last Updated: 2015-04-02
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
236 participants
INTERVENTIONAL
2009-12-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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EN3324 (axomadol)
EN3324 (axomadol)
twice daily dosing
Placebo
Placebo
twice daily dosing
Interventions
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EN3324 (axomadol)
twice daily dosing
Placebo
twice daily dosing
Eligibility Criteria
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Inclusion Criteria
* Are females who are participating abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year.
* Have been on an unchanged regimen of analgesic medication for chronic low back pain on a daily basis for at least 3 months prior to screening; subjects taking opioids must not exceed total daily doses of 90mg oral morphine equivalent
* Have a history of moderate to severe CLBP
Exclusion Criteria
* Have pain secondary to a confirmed or suspected neoplasm
* Intend to alter their physical therapy regimen during the study. Subjects who begin or end physical therapy (either home exercises or formal therapy sessions) 2 weeks prior to screening or during the study period will be excluded from the study
* Have a history or physical examination finding, which may confound pain-related data (e.g., fibromyalgia, radiculopathy)
18 Years
ALL
No
Sponsors
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Grünenthal GmbH
INDUSTRY
Responsible Party
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Locations
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Matthew Doust, MD
Phoenix, Arizona, United States
Paradigm Clinical
Tucson, Arizona, United States
Visions Clinical Research
Tucson, Arizona, United States
Genova Clinical Research, Inc.
Tucson, Arizona, United States
Quality of Life Medical & Research Center
Tuscon, Arizona, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Orange County Clinical Trials, Inc.
Anaheim, California, United States
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, United States
Catalina Research Institute, LLC
Chino, California, United States
Paradigm Clinical Research
Garden Grove, California, United States
Synergy Escondido
La Mesa, California, United States
Triwest Research Associates
La Mesa, California, United States
LBCCR
Long Beach, California, United States
Pacific Institute for Med Research
Los Angeles, California, United States
Samaritan Center for Medical Research
Los Gatos, California, United States
Synergy Research Center
National City, California, United States
Northern California Research
Sacramento, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
Avail Clinical Research
DeLand, Florida, United States
Neuropsychiatric Research Center of SW Florida
Fort Myers, Florida, United States
CNS Healthcare
Jacksonville, Florida, United States
Florida Institute of Medical Research
Jacksonville, Florida, United States
Behavioral Clinical Research, Inc.
Lauderhill, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
CNS Health
Orlando, Florida, United States
Compass Research
Orlando, Florida, United States
Altas Orthopedics & Sports Medicine
Orlando, Florida, United States
Gold Coast Research LLC.
Plantation, Florida, United States
Medex Healthcare Research, Inc.
Chicago, Illinois, United States
Center for Pain Management Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Integrated Clinical Trial Services Inc.
West Des Moines, Iowa, United States
International Clinical Research Institute Inc.
Overland Park, Kansas, United States
Robert Wagner, MD
Crestview Hills, Kentucky, United States
Four Rivers Clinical Research
Paducah, Kentucky, United States
Beacon Clinical Research LLC
Brockton, Massachusetts, United States
Quest Research Institute
Bingham Farms, Michigan, United States
Prime Care Research Associates
Florissant, Missouri, United States
Medex Health Research, Inc.
St Louis, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Office of Danka Micheals, MD
Las Vegas, Nevada, United States
Stephen Miller, MD
Las Vegas, Nevada, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
Finger Lakes Clinical Research
Rochester, New York, United States
New Hanover Medical Research
Wilmington, North Carolina, United States
The Center for Clinical Research, LLC & Carolinas Pain Institute, P.A.
Winstom-Salem, North Carolina, United States
David Schneider, MD
Cincinnari, Ohio, United States
Community Research
Cincinnati, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
Bone, Joint & Spine Surgeons, Inc.
Toledo, Ohio, United States
Neurology & Neruoscience Center of Ohio
Toledo, Ohio, United States
Alleghany Pain Management, PC
Altoona, Pennsylvania, United States
Paragon Clinical Research Inc.
Cranston, Rhode Island, United States
Omega Clinical Research
Warwick, Rhode Island, United States
Future Search Trials
Ausitn, Texas, United States
Austin Diagnostic Clinic
Ausitn, Texas, United States
KRK Medical Research
Dallas, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Medex Healthcare Research
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Countries
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Other Identifiers
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EN3324-201
Identifier Type: -
Identifier Source: org_study_id
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