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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
236
twice daily dosing
twice daily dosing
To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline [Day 0] to final visit [Day 112]
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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.
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Quality of Life Medical & Research Center
Tuscon, Arizona, United States
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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
...and 49 more locations