A Phase 2 interventional study of EN3324 (axomadol) and Placebo in Chronic Low Back Pain, sponsored by Grünenthal GmbH. Completed at 59 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-02.
Sponsored by Grünenthal GmbH · Phase 2, Interventional, and Treatment
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
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 236 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Grünenthal GmbH is the lead sponsor of 65 studies on the registry; 2 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: EN3324 (axomadol)
Drug: Placebo
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]
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Grünenthal GmbH