Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain
- Conditions
- Chronic Low Back Pain
- Interventions
- Drug: EN3324 (axomadol)Drug: Placebo
- Registration Number
- NCT01043263
- Lead Sponsor
- Grünenthal GmbH
- Brief Summary
The purpose of this study is to determine the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain
- Detailed Description
A phase IIB, randomized, double-blind, two-arm, multi-center, placebo-controlled, study to assess the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
- 18 years of age or older
- 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
- Have evidence of or a history of alcohol and/or drug abuse
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EN3324 (axomadol) EN3324 (axomadol) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP. Change from baseline [Day 0] to final visit [Day 112]
- Secondary Outcome Measures
Name Time Method To evaluate patient reported outcomes of EN3324 (axomadol) in subjects with moderate to severe CLBP. Change from baseline [Day 0] to final visit [Day 112] To evaluate the safety, tolerability and efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP. Change from baseline [Day 0] to final visit [Day 112]
Trial Locations
- Locations (59)
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Paradigm Clinical
🇺🇸Tucson, Arizona, United States
Beacon Clinical Research LLC
🇺🇸Brockton, Massachusetts, United States
Office of Danka Micheals, MD
🇺🇸Las Vegas, Nevada, United States
Samaritan Center for Medical Research
🇺🇸Los Gatos, California, United States
Center for Pain Management Rehabilitation Institute of Chicago
🇺🇸Chicago, Illinois, United States
Synergy Escondido
🇺🇸La Mesa, California, United States
Synergy Research Center
🇺🇸National City, California, United States
Robert Wagner, MD
🇺🇸Crestview Hills, Kentucky, United States
Northern California Research
🇺🇸Sacramento, California, United States
Omega Clinical Research
🇺🇸Warwick, Rhode Island, United States
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States
CNS Health
🇺🇸Orlando, Florida, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Florida Institute of Medical Research
🇺🇸Jacksonville, Florida, United States
Orange County Clinical Trials, Inc.
🇺🇸Anaheim, California, United States
Pacific Institute for Med Research
🇺🇸Los Angeles, California, United States
Neuropsychiatric Research Center of SW Florida
🇺🇸Fort Myers, Florida, United States
Sundance Clinical Research
🇺🇸St. Louis, Missouri, United States
Medex Healthcare Research, Inc.
🇺🇸Chicago, Illinois, United States
Triwest Research Associates
🇺🇸La Mesa, California, United States
David Schneider, MD
🇺🇸Cincinnari, Ohio, United States
Behavioral Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Future Search Trials
🇺🇸Ausitn, Texas, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Integrated Clinical Trial Services Inc.
🇺🇸West Des Moines, Iowa, United States
Neurology & Neruoscience Center of Ohio
🇺🇸Toledo, Ohio, United States
KRK Medical Research
🇺🇸Dallas, Texas, United States
Austin Diagnostic Clinic
🇺🇸Ausitn, Texas, United States
Medex Healthcare Research
🇺🇸Houston, Texas, United States
Mountain View Clinical Research
🇺🇸Denver, Colorado, United States
International Clinical Research Institute Inc.
🇺🇸Overland Park, Kansas, United States
Stephen Miller, MD
🇺🇸Las Vegas, Nevada, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
The Center for Clinical Research, LLC & Carolinas Pain Institute, P.A.
🇺🇸Winstom-Salem, North Carolina, United States
Alleghany Pain Management, PC
🇺🇸Altoona, Pennsylvania, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Visions Clinical Research
🇺🇸Tucson, Arizona, United States
Quality of Life Medical & Research Center
🇺🇸Tuscon, Arizona, United States
Associated Pharmaceutical Research Center, Inc.
🇺🇸Buena Park, California, United States
Catalina Research Institute, LLC
🇺🇸Chino, California, United States
LBCCR
🇺🇸Long Beach, California, United States
Avail Clinical Research
🇺🇸DeLand, Florida, United States
CNS Healthcare
🇺🇸Jacksonville, Florida, United States
Segal Institute for Clinical Research
🇺🇸North Miami, 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
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
Paradigm Clinical Research
🇺🇸Garden Grove, California, United States
Matthew Doust, MD
🇺🇸Phoenix, Arizona, United States
Genova Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
Bone, Joint & Spine Surgeons, Inc.
🇺🇸Toledo, Ohio, United States
New Hanover Medical Research
🇺🇸Wilmington, North Carolina, United States
Paragon Clinical Research Inc.
🇺🇸Cranston, Rhode Island, United States
North Star Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States