search
Back to results

Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Matching Placebo
Low Dose GRT6005
Medium Dose GRT6005
High Dose GRT6005
Tapentadol
Sponsored by
Tris Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • AT003
  • AT004
  • AT001
  • AT005
  • AT006
  • BE001
  • BE002
  • BE004
  • DK004
  • DK001
  • Site DK002
  • DK003
  • FI005
  • FI001
  • FI003
  • DE005
  • DE014
  • DE018
  • DE011
  • DE015
  • DE007
  • DE016
  • DE001
  • DE006
  • DE008
  • DE002
  • DE019
  • DE009
  • DE004
  • DE013
  • DE017
  • HU010
  • HU011
  • HU015
  • HU005
  • HU012
  • HU008
  • HU003
  • HU002
  • HU001
  • HU009
  • HU014
  • HU004
  • NL003
  • NL002
  • NL005
  • PL002
  • PL015
  • PL006
  • PL001
  • PL014
  • PL008
  • PL013
  • PL011
  • PL009
  • PL016
  • PL018
  • PL012
  • PL004
  • PL010
  • PL017
  • PL005
  • ES002
  • ES006
  • ES004
  • ES001
  • ES013
  • ES008
  • ES003
  • ES011
  • ES005
  • ES007
  • SE001
  • SE002
  • SE004
  • GB002
  • GB005
  • GB003
  • GB004

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Matching Placebo

Low Dose GRT6005

Medium Dose GRT6005

High Dose GRT6005

Tapentadol

Arm Description

Twice daily oral administration of matching placebo for 14 weeks

Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks.

Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks.

Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks.

Twice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks.

Outcomes

Primary Outcome Measures

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.
United States: the change from baseline pain to the average 24-hour pain during Week 12 of the maintenance phase.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2012
Last Updated
July 13, 2021
Sponsor
Tris Pharma, Inc.
Collaborators
Forest Laboratories
search

1. Study Identification

Unique Protocol Identification Number
NCT01725087
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tris Pharma, Inc.
Collaborators
Forest Laboratories

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1089 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Twice daily oral administration of matching placebo for 14 weeks
Arm Title
Low Dose GRT6005
Arm Type
Experimental
Arm Description
Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks.
Arm Title
Medium Dose GRT6005
Arm Type
Experimental
Arm Description
Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks.
Arm Title
High Dose GRT6005
Arm Type
Experimental
Arm Description
Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks.
Arm Title
Tapentadol
Arm Type
Active Comparator
Arm Description
Twice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Type
Drug
Intervention Name(s)
Low Dose GRT6005
Intervention Type
Drug
Intervention Name(s)
Medium Dose GRT6005
Intervention Type
Drug
Intervention Name(s)
High Dose GRT6005
Intervention Type
Drug
Intervention Name(s)
Tapentadol
Primary Outcome Measure Information:
Title
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.
Time Frame
Baseline to End of Treatment (Week 14)
Title
United States: the change from baseline pain to the average 24-hour pain during Week 12 of the maintenance phase.
Time Frame
Baseline to End of Treatment (Week 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Grünenthal GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
AT003
City
Senftenberg
ZIP/Postal Code
3541
Country
Austria
Facility Name
AT004
City
Wien
ZIP/Postal Code
1060
Country
Austria
Facility Name
AT001
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
AT005
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
AT006
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
BE001
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
BE002
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
BE004
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
DK004
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
DK001
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Site DK002
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
DK003
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
FI005
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
FI001
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
FI003
City
Lahti
ZIP/Postal Code
15110
Country
Finland
Facility Name
DE005
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
DE014
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
DE018
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
DE011
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
DE015
City
Böhlen
ZIP/Postal Code
04564
Country
Germany
Facility Name
DE007
City
Dresden
ZIP/Postal Code
01069
Country
Germany
Facility Name
DE016
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
DE001
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
DE006
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
Facility Name
DE008
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
DE002
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
DE019
City
Leipzig
Country
Germany
Facility Name
DE009
City
Mosbach
ZIP/Postal Code
74821
Country
Germany
Facility Name
DE004
City
Munich
ZIP/Postal Code
80333
Country
Germany
Facility Name
DE013
City
Rodgau
ZIP/Postal Code
63110
Country
Germany
Facility Name
DE017
City
Wiesbaden
ZIP/Postal Code
65185
Country
Germany
Facility Name
HU010
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
HU011
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
HU015
City
Budapest
ZIP/Postal Code
1084
Country
Hungary
Facility Name
HU005
City
Budapest
ZIP/Postal Code
1113
Country
Hungary
Facility Name
HU012
City
Budapest
ZIP/Postal Code
8800
Country
Hungary
Facility Name
HU008
City
Békéscsaba
Country
Hungary
Facility Name
HU003
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
HU002
City
Kiskunfélegyháza
ZIP/Postal Code
6100
Country
Hungary
Facility Name
HU001
City
Mako
ZIP/Postal Code
6900
Country
Hungary
Facility Name
HU009
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Facility Name
HU014
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
HU004
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
NL003
City
Almere
ZIP/Postal Code
1311RL
Country
Netherlands
Facility Name
NL002
City
Eindhoven
ZIP/Postal Code
5623EJ
Country
Netherlands
Facility Name
NL005
City
Tiel
ZIP/Postal Code
4002 WP
Country
Netherlands
Facility Name
PL002
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
PL015
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Facility Name
PL006
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
PL001
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
PL014
City
Katowice
ZIP/Postal Code
40-954
Country
Poland
Facility Name
PL008
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
PL013
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
PL011
City
Krakow
ZIP/Postal Code
31-159
Country
Poland
Facility Name
PL009
City
Lublin
ZIP/Postal Code
20-605
Country
Poland
Facility Name
PL016
City
Poznan
ZIP/Postal Code
60-773
Country
Poland
Facility Name
PL018
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
PL012
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
PL004
City
Warszawa
ZIP/Postal Code
62-3832
Country
Poland
Facility Name
PL010
City
Wroclaw
ZIP/Postal Code
51-162
Country
Poland
Facility Name
PL017
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
PL005
City
Zgierz
ZIP/Postal Code
95-100
Country
Poland
Facility Name
ES002
City
Barcelona
ZIP/Postal Code
08540
Country
Spain
Facility Name
ES006
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Facility Name
ES004
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
ES001
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
ES013
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
ES008
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
ES003
City
Oviedo
ZIP/Postal Code
33009
Country
Spain
Facility Name
ES011
City
Oviedo
ZIP/Postal Code
33013
Country
Spain
Facility Name
ES005
City
Santiago de Compostela
ZIP/Postal Code
15705
Country
Spain
Facility Name
ES007
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
SE001
City
Skene
ZIP/Postal Code
51162
Country
Sweden
Facility Name
SE002
City
Stockholm
ZIP/Postal Code
11522
Country
Sweden
Facility Name
SE004
City
Vällingby
Country
Sweden
Facility Name
GB002
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
GB005
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
GB003
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
GB004
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.

We'll reach out to this number within 24 hrs