Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001920-36 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Matching Placebo | Placebo Comparator | Twice daily oral administration of matching placebo for 14 weeks |
|
| Low Dose GRT6005 | Experimental | Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks. |
|
| Medium Dose GRT6005 | Experimental | Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks. |
|
| High Dose GRT6005 | Experimental | Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks. |
|
| Tapentadol | Active Comparator | Twice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matching Placebo | Drug |
| ||
| Low Dose GRT6005 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to End of Treatment (Week 14) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Grünenthal GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AT003 | Senftenberg | 3541 | Austria | |||
| AT004 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Medium Dose GRT6005 | Drug |
|
| High Dose GRT6005 | Drug |
|
| Tapentadol | Drug |
|
| Vienna |
| 1060 |
| Austria |
| AT001 | Vienna | 1090 | Austria |
| AT005 | Vienna | 1100 | Austria |
| AT006 | Vienna | 1100 | Austria |
| BE001 | Brussels | 1070 | Belgium |
| BE002 | Edegem | 2650 | Belgium |
| BE004 | Genk | 3600 | Belgium |
| DK004 | Aalborg | 9100 | Denmark |
| DK001 | Frederiksberg | 2000 | Denmark |
| Site DK002 | Glostrup Municipality | 2600 | Denmark |
| DK003 | Odense | 5000 | Denmark |
| FI005 | Kokkola | 67100 | Finland |
| FI001 | Kuopio | 70210 | Finland |
| FI003 | Lahti | 15110 | Finland |
| DE005 | Bad Nauheim | 61231 | Germany |
| DE014 | Berlin | 10117 | Germany |
| DE018 | Berlin | 13125 | Germany |
| DE011 | Bochum | 44787 | Germany |
| DE015 | Böhlen | 04564 | Germany |
| DE007 | Dresden | 01069 | Germany |
| DE016 | Essen | 45355 | Germany |
| DE001 | Hamburg | 22415 | Germany |
| DE006 | Hamburg | 22767 | Germany |
| DE008 | Hanover | 30159 | Germany |
| DE002 | Leipzig | 04103 | Germany |
| DE019 | Leipzig | Germany |
| DE009 | Mosbach | 74821 | Germany |
| DE004 | Munich | 80333 | Germany |
| DE013 | Rodgau | 63110 | Germany |
| DE017 | Wiesbaden | 65185 | Germany |
| HU010 | Baja | 6500 | Hungary |
| HU008 | Békéscsaba | Hungary |
| HU011 | Budapest | 1036 | Hungary |
| HU015 | Budapest | 1084 | Hungary |
| HU005 | Budapest | 1113 | Hungary |
| HU012 | Budapest | 8800 | Hungary |
| HU003 | Kecskemét | 6000 | Hungary |
| HU002 | Kiskunfélegyháza | 6100 | Hungary |
| HU001 | Makó | 6900 | Hungary |
| HU009 | Nagykanizsa | 8800 | Hungary |
| HU014 | Nyíregyháza | 4400 | Hungary |
| HU004 | Szekszárd | 7100 | Hungary |
| NL003 | Almere Stad | 1311RL | Netherlands |
| NL002 | Eindhoven | 5623EJ | Netherlands |
| NL005 | Tiel | 4002 WP | Netherlands |
| PL002 | Elblag | 82-300 | Poland |
| PL015 | Gdynia | 81-338 | Poland |
| PL006 | Gdynia | 81-384 | Poland |
| PL001 | Katowice | 40-040 | Poland |
| PL014 | Katowice | 40-954 | Poland |
| PL008 | Krakow | 30-510 | Poland |
| PL013 | Krakow | 30-510 | Poland |
| PL011 | Krakow | 31-159 | Poland |
| PL009 | Lublin | 20-605 | Poland |
| PL016 | Poznan | 60-773 | Poland |
| PL018 | Poznan | 61-397 | Poland |
| PL012 | Warsaw | 01-868 | Poland |
| PL004 | Warsaw | 62-3832 | Poland |
| PL010 | Wroclaw | 51-162 | Poland |
| PL017 | Wroclaw | 53-114 | Poland |
| PL005 | Zgierz | 95-100 | Poland |
| ES004 | A Coruña | 15006 | Spain |
| ES002 | Barcelona | 08540 | Spain |
| ES006 | Barcelona | 8023 | Spain |
| ES001 | Madrid | 28046 | Spain |
| ES013 | Madrid | 28050 | Spain |
| ES008 | Málaga | 29009 | Spain |
| ES003 | Oviedo | 33009 | Spain |
| ES011 | Oviedo | 33013 | Spain |
| ES005 | Santiago de Compostela | 15705 | Spain |
| ES007 | Seville | 41071 | Spain |
| SE001 | Skene | 51162 | Sweden |
| SE002 | Stockholm | 11522 | Sweden |
| SE004 | Vällingby | Sweden |
| GB002 | Liverpool | L22 0LG | United Kingdom |
| GB005 | London | SE1 7EH | United Kingdom |
| GB003 | Manchester | M15 6SX | United Kingdom |
| GB004 | Plymouth | PL6 8DH | United Kingdom |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077432 | Tapentadol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided