Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain
CLBP
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
1 other identifier
interventional
236
1 country
59
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2009
Shorter than P25 for phase_2
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 18, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedApril 2, 2015
March 1, 2015
1.5 years
December 18, 2009
March 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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]
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]
Study Arms (2)
EN3324 (axomadol)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grünenthal GmbHlead
Study Sites (59)
Matthew Doust, MD
Phoenix, Arizona, 85050, United States
Paradigm Clinical
Tucson, Arizona, 85705, United States
Visions Clinical Research
Tucson, Arizona, 85712, United States
Genova Clinical Research, Inc.
Tucson, Arizona, 85741, United States
Quality of Life Medical & Research Center
Tuscon, Arizona, 85715, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Orange County Clinical Trials, Inc.
Anaheim, California, 92801, United States
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, 90620, United States
Catalina Research Institute, LLC
Chino, California, 91710, United States
Paradigm Clinical Research
Garden Grove, California, 92844, United States
Synergy Escondido
La Mesa, California, 91942, United States
Triwest Research Associates
La Mesa, California, 91942, United States
LBCCR
Long Beach, California, 90806, United States
Pacific Institute for Med Research
Los Angeles, California, 90024, United States
Samaritan Center for Medical Research
Los Gatos, California, 95032, United States
Synergy Research Center
National City, California, 91950, United States
Northern California Research
Sacramento, California, 95821, United States
Mountain View Clinical Research
Denver, Colorado, 80209, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
Neuropsychiatric Research Center of SW Florida
Fort Myers, Florida, 33912, United States
CNS Healthcare
Jacksonville, Florida, 32216, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32257, United States
Behavioral Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
CNS Health
Orlando, Florida, 32806, United States
Compass Research
Orlando, Florida, 32806, United States
Altas Orthopedics & Sports Medicine
Orlando, Florida, 32822, United States
Gold Coast Research LLC.
Plantation, Florida, 33324, United States
Medex Healthcare Research, Inc.
Chicago, Illinois, 60603, United States
Center for Pain Management Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Integrated Clinical Trial Services Inc.
West Des Moines, Iowa, 50265, United States
International Clinical Research Institute Inc.
Overland Park, Kansas, 66211, United States
Robert Wagner, MD
Crestview Hills, Kentucky, 41017, United States
Four Rivers Clinical Research
Paducah, Kentucky, 42003, United States
Beacon Clinical Research LLC
Brockton, Massachusetts, 02301, United States
Quest Research Institute
Bingham Farms, Michigan, 48025, United States
Prime Care Research Associates
Florissant, Missouri, 63031, United States
Medex Health Research, Inc.
St Louis, Missouri, 63117, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
Office of Danka Micheals, MD
Las Vegas, Nevada, 89128, United States
Stephen Miller, MD
Las Vegas, Nevada, 89144, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
New Hanover Medical Research
Wilmington, North Carolina, 28401, United States
The Center for Clinical Research, LLC & Carolinas Pain Institute, P.A.
Winstom-Salem, North Carolina, 27103, United States
David Schneider, MD
Cincinnari, Ohio, 45245, United States
Community Research
Cincinnati, Ohio, 45227, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
Bone, Joint & Spine Surgeons, Inc.
Toledo, Ohio, 43623, United States
Neurology & Neruoscience Center of Ohio
Toledo, Ohio, 43623, United States
Alleghany Pain Management, PC
Altoona, Pennsylvania, 16602, United States
Paragon Clinical Research Inc.
Cranston, Rhode Island, 02920, United States
Omega Clinical Research
Warwick, Rhode Island, 02818, United States
Future Search Trials
Ausitn, Texas, 78756, United States
Austin Diagnostic Clinic
Ausitn, Texas, 78758, United States
KRK Medical Research
Dallas, Texas, 75230, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Medex Healthcare Research
Houston, Texas, 77074, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2009
First Posted
January 6, 2010
Study Start
December 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
April 2, 2015
Record last verified: 2015-03