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

Sponsor
Tris Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01725087
Collaborator
Forest Laboratories (Industry)
1,089
Enrollment
79
Locations
5
Arms
19.9
Duration (Months)
13.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Matching Placebo
  • Drug: Low Dose GRT6005
  • Drug: Medium Dose GRT6005
  • Drug: High Dose GRT6005
  • Drug: Tapentadol
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
1089 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain.
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Matching Placebo

Twice daily oral administration of matching placebo for 14 weeks

Drug: Matching Placebo
Experimental: Low Dose GRT6005

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

Drug: Low Dose GRT6005
Experimental: Medium Dose GRT6005

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

Drug: Medium Dose GRT6005
Experimental: High Dose GRT6005

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

Drug: High Dose GRT6005
Active Comparator: Tapentadol

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

Drug: Tapentadol

Outcome Measures

Primary Outcome Measures

  1. 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)]

  2. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 AT003 Senftenberg Austria 3541
2 AT004 Wien Austria 1060
3 AT001 Wien Austria 1090
4 AT005 Wien Austria 1100
5 AT006 Wien Austria 1100
6 BE001 Bruxelles Belgium 1070
7 BE002 Edegem Belgium 2650
8 BE004 Genk Belgium 3600
9 DK004 Aalborg Denmark 9100
10 DK001 Frederiksberg Denmark 2000
11 Site DK002 Glostrup Denmark 2600
12 DK003 Odense Denmark 5000
13 FI005 Kokkola Finland 67100
14 FI001 Kuopio Finland 70210
15 FI003 Lahti Finland 15110
16 DE005 Bad Nauheim Germany 61231
17 DE014 Berlin Germany 10117
18 DE018 Berlin Germany 13125
19 DE011 Bochum Germany 44787
20 DE015 Böhlen Germany 04564
21 DE007 Dresden Germany 01069
22 DE016 Essen Germany 45355
23 DE001 Hamburg Germany 22415
24 DE006 Hamburg Germany 22767
25 DE008 Hannover Germany 30159
26 DE002 Leipzig Germany 04103
27 DE019 Leipzig Germany
28 DE009 Mosbach Germany 74821
29 DE004 Munich Germany 80333
30 DE013 Rodgau Germany 63110
31 DE017 Wiesbaden Germany 65185
32 HU010 Baja Hungary 6500
33 HU011 Budapest Hungary 1036
34 HU015 Budapest Hungary 1084
35 HU005 Budapest Hungary 1113
36 HU012 Budapest Hungary 8800
37 HU008 Békéscsaba Hungary
38 HU003 Kecskemet Hungary 6000
39 HU002 Kiskunfélegyháza Hungary 6100
40 HU001 Mako Hungary 6900
41 HU009 Nagykanizsa Hungary 8800
42 HU014 Nyiregyhaza Hungary 4400
43 HU004 Szekszárd Hungary 7100
44 NL003 Almere Netherlands 1311RL
45 NL002 Eindhoven Netherlands 5623EJ
46 NL005 Tiel Netherlands 4002 WP
47 PL002 Elblag Poland 82-300
48 PL015 Gdynia Poland 81-338
49 PL006 Gdynia Poland 81-384
50 PL001 Katowice Poland 40-040
51 PL014 Katowice Poland 40-954
52 PL008 Krakow Poland 30-510
53 PL013 Krakow Poland 30-510
54 PL011 Krakow Poland 31-159
55 PL009 Lublin Poland 20-605
56 PL016 Poznan Poland 60-773
57 PL018 Poznan Poland 61-397
58 PL012 Warszawa Poland 01-868
59 PL004 Warszawa Poland 62-3832
60 PL010 Wroclaw Poland 51-162
61 PL017 Wroclaw Poland 53-114
62 PL005 Zgierz Poland 95-100
63 ES002 Barcelona Spain 08540
64 ES006 Barcelona Spain 8023
65 ES004 La Coruna Spain 15006
66 ES001 Madrid Spain 28046
67 ES013 Madrid Spain 28050
68 ES008 Málaga Spain 29009
69 ES003 Oviedo Spain 33009
70 ES011 Oviedo Spain 33013
71 ES005 Santiago de Compostela Spain 15705
72 ES007 Sevilla Spain 41071
73 SE001 Skene Sweden 51162
74 SE002 Stockholm Sweden 11522
75 SE004 Vällingby Sweden
76 GB002 Liverpool United Kingdom L22 0LG
77 GB005 London United Kingdom SE1 7EH
78 GB003 Manchester United Kingdom M15 6SX
79 GB004 Plymouth United Kingdom PL6 8DH

Sponsors and Collaborators

  • Tris Pharma, Inc.
  • Forest Laboratories

Investigators

  • Study Chair: Study Director, Grünenthal GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tris Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01725087
Other Study ID Numbers:
  • KF6005/06
  • 2012-001920-36
First Posted:
Nov 12, 2012
Last Update Posted:
Jul 15, 2021
Last Verified:
Jul 1, 2021
Additional relevant MeSH terms:
Back Pain
Low Back Pain
Tapentadol

Study Results

No Results Posted as of Jul 15, 2021