Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.
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.
Low Back Pain
Drug: Matching Placebo
Drug: Low Dose GRT6005
Drug: Medium Dose GRT6005
Drug: High Dose GRT6005
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain.|
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Matching Placebo
Twice daily oral administration of matching placebo for 14 weeks
|Drug: Matching Placebo|
Experimental: Low Dose GRT6005
Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks.
|Drug: Low Dose GRT6005|
Experimental: Medium Dose GRT6005
Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks.
|Drug: Medium Dose GRT6005|
Experimental: High Dose GRT6005
Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks.
|Drug: High Dose GRT6005|
Active Comparator: Tapentadol
Twice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks.
|Contact: Grünenthal Clinical Trial Helpdesk||+49 241 569 firstname.lastname@example.org|
|Contact: René Allard||+49 241 569 email@example.com|
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|Study Chair:||Study Director||Grünenthal GmbH|