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

July 13, 2021 updated by: Tris Pharma, Inc.

Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1089

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Senftenberg, Austria, 3541
        • AT003
      • Wien, Austria, 1060
        • AT004
      • Wien, Austria, 1090
        • AT001
      • Wien, Austria, 1100
        • AT005
      • Wien, Austria, 1100
        • AT006
  • Belgium
      • Bruxelles, Belgium, 1070
        • BE001
      • Edegem, Belgium, 2650
        • BE002
      • Genk, Belgium, 3600
        • BE004
  • Denmark
      • Aalborg, Denmark, 9100
        • DK004
      • Frederiksberg, Denmark, 2000
        • DK001
      • Glostrup, Denmark, 2600
        • Site DK002
      • Odense, Denmark, 5000
        • DK003
  • Finland
      • Kokkola, Finland, 67100
        • FI005
      • Kuopio, Finland, 70210
        • FI001
      • Lahti, Finland, 15110
        • FI003
  • Germany
      • Bad Nauheim, Germany, 61231
        • DE005
      • Berlin, Germany, 10117
        • DE014
      • Berlin, Germany, 13125
        • DE018
      • Bochum, Germany, 44787
        • DE011
      • Böhlen, Germany, 04564
        • DE015
      • Dresden, Germany, 01069
        • DE007
      • Essen, Germany, 45355
        • DE016
      • Hamburg, Germany, 22415
        • DE001
      • Hamburg, Germany, 22767
        • DE006
      • Hannover, Germany, 30159
        • DE008
      • Leipzig, Germany, 04103
        • DE002
      • Leipzig, Germany
        • DE019
      • Mosbach, Germany, 74821
        • DE009
      • Munich, Germany, 80333
        • DE004
      • Rodgau, Germany, 63110
        • DE013
      • Wiesbaden, Germany, 65185
        • DE017
  • Hungary
      • Baja, Hungary, 6500
        • HU010
      • Budapest, Hungary, 1036
        • HU011
      • Budapest, Hungary, 1084
        • HU015
      • Budapest, Hungary, 1113
        • HU005
      • Budapest, Hungary, 8800
        • HU012
      • Békéscsaba, Hungary
        • HU008
      • Kecskemet, Hungary, 6000
        • HU003
      • Kiskunfélegyháza, Hungary, 6100
        • HU002
      • Mako, Hungary, 6900
        • HU001
      • Nagykanizsa, Hungary, 8800
        • HU009
      • Nyiregyhaza, Hungary, 4400
        • HU014
      • Szekszárd, Hungary, 7100
        • HU004
  • Netherlands
      • Almere, Netherlands, 1311RL
        • NL003
      • Eindhoven, Netherlands, 5623EJ
        • NL002
      • Tiel, Netherlands, 4002 WP
        • NL005
  • Poland
      • Elblag, Poland, 82-300
        • PL002
      • Gdynia, Poland, 81-338
        • PL015
      • Gdynia, Poland, 81-384
        • PL006
      • Katowice, Poland, 40-040
        • PL001
      • Katowice, Poland, 40-954
        • PL014
      • Krakow, Poland, 30-510
        • PL008
      • Krakow, Poland, 30-510
        • PL013
      • Krakow, Poland, 31-159
        • PL011
      • Lublin, Poland, 20-605
        • PL009
      • Poznan, Poland, 60-773
        • PL016
      • Poznan, Poland, 61-397
        • PL018
      • Warszawa, Poland, 01-868
        • PL012
      • Warszawa, Poland, 62-3832
        • PL004
      • Wroclaw, Poland, 51-162
        • PL010
      • Wroclaw, Poland, 53-114
        • PL017
      • Zgierz, Poland, 95-100
        • PL005
  • Spain
      • Barcelona, Spain, 08540
        • ES002
      • Barcelona, Spain, 8023
        • ES006
      • La Coruna, Spain, 15006
        • ES004
      • Madrid, Spain, 28046
        • ES001
      • Madrid, Spain, 28050
        • ES013
      • Málaga, Spain, 29009
        • ES008
      • Oviedo, Spain, 33009
        • ES003
      • Oviedo, Spain, 33013
        • ES011
      • Santiago de Compostela, Spain, 15705
        • ES005
      • Sevilla, Spain, 41071
        • ES007
  • Sweden
      • Skene, Sweden, 51162
        • SE001
      • Stockholm, Sweden, 11522
        • SE002
      • Vällingby, Sweden
        • SE004
  • United Kingdom
      • Liverpool, United Kingdom, L22 0LG
        • GB002
      • London, United Kingdom, SE1 7EH
        • GB005
      • Manchester, United Kingdom, M15 6SX
        • GB003
      • Plymouth, United Kingdom, PL6 8DH
        • GB004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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.
Time Frame: Baseline to End of Treatment (Week 14)
Baseline to End of Treatment (Week 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tris Pharma, Inc.

Collaborators

Forest Laboratories

Investigators

  • Study Chair: Study Director, Grünenthal GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

November 8, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (ESTIMATE)

November 12, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF6005/06
  • 2012-001920-36 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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