Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.
Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain.
2 other identifiers
interventional
1,089
11 countries
79
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 low-back-pain
Started Nov 2012
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 8, 2012
CompletedFirst Posted
Study publicly available on registry
November 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 15, 2021
July 1, 2021
1.7 years
November 8, 2012
July 13, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (5)
Matching Placebo
PLACEBO COMPARATORTwice daily oral administration of matching placebo for 14 weeks
Low Dose GRT6005
EXPERIMENTALOnce daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks.
Medium Dose GRT6005
EXPERIMENTALOnce daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks.
High Dose GRT6005
EXPERIMENTALOnce daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks.
Tapentadol
ACTIVE COMPARATORTwice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tris Pharma, Inc.lead
- Forest Laboratoriescollaborator
Study Sites (79)
AT003
Senftenberg, 3541, Austria
AT004
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Study Director
Grünenthal GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2012
First Posted
November 12, 2012
Study Start
November 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
July 15, 2021
Record last verified: 2021-07