Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain (CLBP)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)