Clinical trial NCT01725087: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Lead sponsor: Tris Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2012-11-12
Enrollment: 1089
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: 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.
timeFrame: Baseline to End of Treatment (Week 14)
measure: United States: the change from baseline pain to the average 24-hour pain during Week 12 of the maintenance phase.
timeFrame: Baseline to End of Treatment (Week 14)
Secondary outcomes:
Other outcomes:
Locations:
city: Senftenberg
country: Austria
facility: AT003
city: Wien
country: Austria
facility: AT004
city: Wien
country: Austria
facility: AT001
city: Wien
country: Austria
facility: AT005
city: Wien
country: Austria
facility: AT006
city: Bruxelles
country: Belgium
facility: BE001
city: Edegem
country: Belgium
facility: BE002
city: Genk
country: Belgium
facility: BE004
city: Aalborg
country: Denmark
facility: DK004
city: Frederiksberg
country: Denmark
facility: DK001
city: Glostrup
country: Denmark
facility: Site DK002
city: Odense
country: Denmark
facility: DK003
city: Kokkola
country: Finland
facility: FI005
city: Kuopio
country: Finland
facility: FI001
city: Lahti
country: Finland
facility: FI003
city: Bad Nauheim
country: Germany
facility: DE005
city: Berlin
country: Germany
facility: DE014
city: Berlin
country: Germany
facility: DE018
city: Bochum
country: Germany
facility: DE011
city: Böhlen
country: Germany
facility: DE015
city: Dresden
country: Germany
facility: DE007
city: Essen
country: Germany
facility: DE016
city: Hamburg
country: Germany
facility: DE001
city: Hamburg
country: Germany
facility: DE006
city: Hannover
country: Germany
facility: DE008
city: Leipzig
country: Germany
facility: DE002
city: Leipzig
country: Germany
facility: DE019
city: Mosbach
country: Germany
facility: DE009
city: Munich
country: Germany
facility: DE004
city: Rodgau
country: Germany
facility: DE013
city: Wiesbaden
country: Germany
facility: DE017
city: Baja
country: Hungary
facility: HU010
city: Budapest
country: Hungary
facility: HU011
city: Budapest
country: Hungary
facility: HU015
city: Budapest
country: Hungary
facility: HU005
city: Budapest
country: Hungary
facility: HU012
city: Békéscsaba
country: Hungary
facility: HU008
city: Kecskemet
country: Hungary
facility: HU003
city: Kiskunfélegyháza
country: Hungary
facility: HU002
city: Mako
country: Hungary
facility: HU001
city: Nagykanizsa
country: Hungary
facility: HU009
city: Nyiregyhaza
country: Hungary
facility: HU014
city: Szekszárd
country: Hungary
facility: HU004
city: Almere
country: Netherlands
facility: NL003
city: Eindhoven
country: Netherlands
facility: NL002
city: Tiel
country: Netherlands
facility: NL005
city: Elblag
country: Poland
facility: PL002
city: Gdynia
country: Poland
facility: PL015
city: Gdynia
country: Poland
facility: PL006
city: Katowice
country: Poland
facility: PL001
city: Katowice
country: Poland
facility: PL014
city: Krakow
country: Poland
facility: PL008
city: Krakow
country: Poland
facility: PL013
city: Krakow
country: Poland
facility: PL011
city: Lublin
country: Poland
facility: PL009
city: Poznan
country: Poland
facility: PL016
city: Poznan
country: Poland
facility: PL018
city: Warszawa
country: Poland
facility: PL012
city: Warszawa
country: Poland
facility: PL004
city: Wroclaw
country: Poland
facility: PL010
city: Wroclaw
country: Poland
facility: PL017
city: Zgierz
country: Poland
facility: PL005
city: Barcelona
country: Spain
facility: ES002
city: Barcelona
country: Spain
facility: ES006
city: La Coruna
country: Spain
facility: ES004
city: Madrid
country: Spain
facility: ES001
city: Madrid
country: Spain
facility: ES013
city: Málaga
country: Spain
facility: ES008
city: Oviedo
country: Spain
facility: ES003
city: Oviedo
country: Spain
facility: ES011
city: Santiago de Compostela
country: Spain
facility: ES005
city: Sevilla
country: Spain
facility: ES007
city: Skene
country: Sweden
facility: SE001
city: Stockholm
country: Sweden
facility: SE002
city: Vällingby
country: Sweden
facility: SE004
city: Liverpool
country: United Kingdom
facility: GB002
city: London
country: United Kingdom
facility: GB005
city: Manchester
country: United Kingdom
facility: GB003
city: Plymouth
country: United Kingdom
facility: GB004
Study officials:
affiliation: Grünenthal GmbH
name: Study Director
role: STUDY_CHAIR
References: