Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
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.