Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Low Back Pain |
| Intervention | Drug: Matching Placebo Drug: Low Dose GRT6005 Drug: Medium Dose GRT6005 Drug: High Dose GRT6005 Drug: Tapentadol |
| Phase | Phase 2 |
| Sponsor | Grünenthal GmbH |
| Responsible Party | Grünenthal GmbH |
| ClinicalTrials.gov Identifier | NCT01725087 |
| First Received | November 8, 2012 |
| Last Updated | April 17, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 8, 2012 |
|---|---|
| Last Updated Date | April 17, 2014 |
| Start Date | November 2012 |
| Estimated Primary Completion Date | March 2014 |
| Current Primary Outcome Measures |
|
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain. |
|---|---|
| Official Title | Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain. |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Low Back Pain |
| Intervention | Drug: Matching Placebo Drug: Low Dose GRT6005 Drug: Medium Dose GRT6005 Drug: High Dose GRT6005 Drug: Tapentadol |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 1089 |
| Estimated Completion Date | March 2014 |
| Estimated Primary Completion Date | March 2014 |
| Eligibility Criteria | Inclusion Criteria: - Chronic Low Back Pain of non-malignant origin and present for at least 3 months. - Signed informed consent. - Pain intensity score of 5 or greater on the 11-point numeric rating scale (where 0 indicates "no pain" and 10 indicates "as bad as you can imagine"). - On stable analgesic medications (non-opioid and/or opioid medications) for chronic low back pain with regular intake for at least 3 months and dissatisfied with current analgesic treatment. Exclusion Criteria: - Female subjects who are pregnant or are breastfeeding. - Presence of risk factors for Torsade de Pointes. - Any clinically significant disease or laboratory findings that may affect efficacy or safety assessments or may compromise the safety during trial participation, e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, metabolic, neurological, or psychiatric disorders. - History of acute hepatitis within the past 3 months or chronic hepatitis or a positive result on anti-hepatitis A antibody, hepatitis B surface antigen, or anti-hepatitis C antibody. History of human immunodeficiency virus (HIV) infection. - History of seizure disorder. - Chronic low back pain potentially associated with a specific spinal cause. - Surgery or painful procedure during or within 3 months of enrollment. - Conditions that contribute and confound the assessment of pain. - Subjects with impaired renal function. - Subjects with impaired hepatic functionality. - Neuromodulation. - Cancer. - Clinically relevant history of hypersensitivity, allergy or contraindications to any of the Investigational Medicinal Products' excipients, paracetamol/acetaminophen, tapentadol Hydrochloride, or opioid analgesics (or excipients). |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Austria, Belgium, Denmark, Finland, Germany, Hungary, Netherlands, Poland, Spain, Sweden, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01725087 |
|---|---|
| Other Study ID Numbers | KF6005/06 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Grünenthal GmbH |
| Study Sponsor | Grünenthal GmbH |
| Collaborators | Forest Laboratories |
| Investigators | Study Chair: Study Director Grünenthal GmbH |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| AT003 | Senftenberg, Austria, 3541 |
|---|---|
| AT001 | Wien, Austria, 1090 |
| AT004 | Wien, Austria, 1060 |
| AT005 | Wien, Austria, 1100 |
| AT006 | Wien, Austria, 1100 |
| BE001 | Bruxelles, Belgium, 1070 |
| BE002 | Edegem, Belgium, 2650 |
| BE004 | Genk, Belgium, 3600 |
| DK004 | Aalborg, Denmark, 9100 |
| DK001 | Frederiksberg, Denmark, 2000 |
| Site DK002 | Glostrup, Denmark, 2600 |
| DK003 | Odense, Denmark, 5000 |
| FI005 | Kokkola, Finland, 67100 |
| FI001 | Kuopio, Finland, 70210 |
| FI003 | Lahti, Finland, 15110 |
| DE005 | Bad Nauheim, Germany, 61231 |
| DE014 | Berlin, Germany, 10117 |
| DE018 | Berlin, Germany, 13125 |
| DE011 | Bochum, Germany, 44787 |
| DE015 | Böhlen, Germany, 04564 |
| DE007 | Dresden, Germany, 01069 |
| DE016 | Essen, Germany, 45355 |
| DE001 | Hamburg, Germany, 22415 |
| DE006 | Hamburg, Germany, 22767 |
| DE008 | Hannover, Germany, 30159 |
| DE002 | Leipzig, Germany, 04103 |
| DE019 | Leipzig, Germany |
| DE009 | Mosbach, Germany, 74821 |
| DE004 | Munich, Germany, 80333 |
| DE013 | Rodgau, Germany, 63110 |
| DE017 | Wiesbaden, Germany, 65185 |
| HU010 | Baja, Hungary, 6500 |
| HU011 | Budapest, Hungary, 1036 |
| HU005 | Budapest, Hungary, 1113 |
| HU012 | Budapest, Hungary, 8800 |
| HU015 | Budapest, Hungary, 1084 |
| HU008 | Békéscsaba, Hungary |
| HU003 | Kecskemet, Hungary, 6000 |
| HU002 | Kiskunfélegyháza, Hungary, 6100 |
| HU001 | Mako, Hungary, 6900 |
| HU009 | Nagykanizsa, Hungary, 8800 |
| HU014 | Nyiregyhaza, Hungary, 4400 |
| HU004 | Szekszárd, Hungary, 7100 |
| NL003 | Almere, Netherlands, 1311RL |
| NL002 | Eindhoven, Netherlands, 5623EJ |
| NL005 | Tiel, Netherlands, 4002 WP |
| PL002 | Elblag, Poland, 82-300 |
| PL006 | Gdynia, Poland, 81-384 |
| PL015 | Gdynia, Poland, 81-338 |
| PL001 | Katowice, Poland, 40-040 |
| PL014 | Katowice, Poland, 40-954 |
| PL011 | Krakow, Poland, 31-159 |
| PL013 | Krakow, Poland, 30-510 |
| PL008 | Krakow, Poland, 30-510 |
| PL009 | Lublin, Poland, 20-605 |
| PL016 | Poznan, Poland, 60-773 |
| PL018 | Poznan, Poland, 61-397 |
| PL004 | Warszawa, Poland, 62-3832 |
| PL012 | Warszawa, Poland, 01-868 |
| PL010 | Wroclaw, Poland, 51-162 |
| PL017 | Wroclaw, Poland, 53-114 |
| PL005 | Zgierz, Poland, 95-100 |
| ES002 | Barcelona, Spain, 08540 |
| ES006 | Barcelona, Spain, 8023 |
| ES004 | La Coruna, Spain, 15006 |
| ES001 | Madrid, Spain, 28046 |
| ES013 | Madrid, Spain, 28050 |
| ES008 | Málaga, Spain, 29009 |
| ES011 | Oviedo, Spain, 33013 |
| ES003 | Oviedo, Spain, 33009 |
| ES005 | Santiago de Compostela, Spain, 15705 |
| ES007 | Sevilla, Spain, 41071 |
| SE001 | Skene, Sweden, 51162 |
| SE002 | Stockholm, Sweden, 11522 |
| SE004 | Vällingby, Sweden |
| GB002 | Liverpool, United Kingdom, L22 0LG |
| GB005 | London, United Kingdom, SE1 7EH |
| GB003 | Manchester, United Kingdom, M15 6SX |
| GB004 | Plymouth, United Kingdom, PL6 8DH |