The purpose of this trial is to evaluate the safety and efficacy of once daily orally administered GRT6005 in a total of 3 fixed doses compared to placebo in subjects with moderate to severe chronic Low Back Pain (LBP). The study includes a maximum of 21 days screening period followed by a 2-week titration period and 12-week maintenance double-blind treatment period and a 10-14 day safety follow up period. Patients who are eligible for the double-blind treatment period will be randomized to one of the following treatment groups: GRT6005 low-dose, GRT6005 medium dose, GRT6005 high-dose, Tapentadol or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,089
European Union: the change from baseline pain to the weekly average 24-hour pain during the entire 12 weeks of the maintenance phase of the double-blind Treatment Period.
Time frame: Baseline to End of Treatment (Week 14)
United States: the change from baseline pain to the average 24-hour pain during Week 12 of the maintenance phase.
Time frame: Baseline to End of Treatment (Week 14)
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AT003
Senftenberg, Austria
AT004
Vienna, Austria
AT001
Vienna, Austria
AT005
Vienna, Austria
AT006
Vienna, Austria
BE001
Brussels, Belgium
BE002
Edegem, Belgium
BE004
Genk, Belgium
DK004
Aalborg, Denmark
DK001
Frederiksberg, Denmark
...and 69 more locations