Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.
- Conditions
- Low Back Pain
- Interventions
- Drug: High Dose GRT6005Drug: TapentadolDrug: Low Dose GRT6005Drug: Medium Dose GRT6005Drug: Matching Placebo
- Registration Number
- NCT01725087
- Lead Sponsor
- Tris Pharma, Inc.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1089
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Dose GRT6005 High Dose GRT6005 Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks. Tapentadol Tapentadol Twice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks. Low Dose GRT6005 Low Dose GRT6005 Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks. Medium Dose GRT6005 Medium Dose GRT6005 Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks. Matching Placebo Matching Placebo Twice daily oral administration of matching placebo for 14 weeks
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (79)
FI005
🇫🇮Kokkola, Finland
AT001
🇦🇹Wien, Austria
AT005
🇦🇹Wien, Austria
FI003
🇫🇮Lahti, Finland
BE002
🇧🇪Edegem, Belgium
FI001
🇫🇮Kuopio, Finland
AT003
🇦🇹Senftenberg, Austria
BE001
🇧🇪Bruxelles, Belgium
AT004
🇦🇹Wien, Austria
NL003
🇳🇱Almere, Netherlands
DE016
🇩🇪Essen, Germany
HU004
ðŸ‡ðŸ‡ºSzekszárd, Hungary
DE018
🇩🇪Berlin, Germany
HU008
ðŸ‡ðŸ‡ºBékéscsaba, Hungary
HU012
ðŸ‡ðŸ‡ºBudapest, Hungary
HU001
ðŸ‡ðŸ‡ºMako, Hungary
HU009
ðŸ‡ðŸ‡ºNagykanizsa, Hungary
PL015
🇵🇱Gdynia, Poland
HU014
ðŸ‡ðŸ‡ºNyiregyhaza, Hungary
PL002
🇵🇱Elblag, Poland
PL001
🇵🇱Katowice, Poland
PL018
🇵🇱Poznan, Poland
PL010
🇵🇱Wroclaw, Poland
NL002
🇳🇱Eindhoven, Netherlands
ES002
🇪🇸Barcelona, Spain
PL016
🇵🇱Poznan, Poland
PL012
🇵🇱Warszawa, Poland
PL011
🇵🇱Krakow, Poland
GB004
🇬🇧Plymouth, United Kingdom
PL017
🇵🇱Wroclaw, Poland
ES013
🇪🇸Madrid, Spain
ES001
🇪🇸Madrid, Spain
GB003
🇬🇧Manchester, United Kingdom
DK004
🇩🇰Aalborg, Denmark
DK001
🇩🇰Frederiksberg, Denmark
Site DK002
🇩🇰Glostrup, Denmark
DK003
🇩🇰Odense, Denmark
AT006
🇦🇹Wien, Austria
BE004
🇧🇪Genk, Belgium
DE001
🇩🇪Hamburg, Germany
DE005
🇩🇪Bad Nauheim, Germany
DE014
🇩🇪Berlin, Germany
DE011
🇩🇪Bochum, Germany
DE007
🇩🇪Dresden, Germany
DE015
🇩🇪Böhlen, Germany
DE006
🇩🇪Hamburg, Germany
DE008
🇩🇪Hannover, Germany
DE002
🇩🇪Leipzig, Germany
DE013
🇩🇪Rodgau, Germany
DE019
🇩🇪Leipzig, Germany
HU005
ðŸ‡ðŸ‡ºBudapest, Hungary
DE009
🇩🇪Mosbach, Germany
DE017
🇩🇪Wiesbaden, Germany
HU010
ðŸ‡ðŸ‡ºBaja, Hungary
HU002
ðŸ‡ðŸ‡ºKiskunfélegyháza, Hungary
HU003
ðŸ‡ðŸ‡ºKecskemet, Hungary
NL005
🇳🇱Tiel, Netherlands
PL008
🇵🇱Krakow, Poland
PL014
🇵🇱Katowice, Poland
PL004
🇵🇱Warszawa, Poland
ES006
🇪🇸Barcelona, Spain
ES004
🇪🇸La Coruna, Spain
ES008
🇪🇸Málaga, Spain
ES003
🇪🇸Oviedo, Spain
ES011
🇪🇸Oviedo, Spain
ES005
🇪🇸Santiago de Compostela, Spain
SE001
🇸🇪Skene, Sweden
ES007
🇪🇸Sevilla, Spain
GB005
🇬🇧London, United Kingdom
SE002
🇸🇪Stockholm, Sweden
SE004
🇸🇪Vällingby, Sweden
GB002
🇬🇧Liverpool, United Kingdom
HU011
ðŸ‡ðŸ‡ºBudapest, Hungary
HU015
ðŸ‡ðŸ‡ºBudapest, Hungary
DE004
🇩🇪Munich, Germany
PL006
🇵🇱Gdynia, Poland
PL005
🇵🇱Zgierz, Poland
PL009
🇵🇱Lublin, Poland
PL013
🇵🇱Krakow, Poland