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

NCT ID: NCT01725087

Last Updated: 2021-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1089 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Matching Placebo

Twice daily oral administration of matching placebo for 14 weeks

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Low Dose GRT6005

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

Group Type EXPERIMENTAL

Low Dose GRT6005

Intervention Type DRUG

Medium Dose GRT6005

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

Group Type EXPERIMENTAL

Medium Dose GRT6005

Intervention Type DRUG

High Dose GRT6005

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

Group Type EXPERIMENTAL

High Dose GRT6005

Intervention Type DRUG

Tapentadol

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

Group Type ACTIVE_COMPARATOR

Tapentadol

Intervention Type DRUG

Interventions

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Matching Placebo

Intervention Type DRUG

Low Dose GRT6005

Intervention Type DRUG

Medium Dose GRT6005

Intervention Type DRUG

High Dose GRT6005

Intervention Type DRUG

Tapentadol

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Tris Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_CHAIR

Grünenthal GmbH

Locations

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AT003

Senftenberg, , Austria

Site Status

AT004

Vienna, , Austria

Site Status

AT001

Vienna, , Austria

Site Status

AT005

Vienna, , Austria

Site Status

AT006

Vienna, , Austria

Site Status

BE001

Brussels, , Belgium

Site Status

BE002

Edegem, , Belgium

Site Status

BE004

Genk, , Belgium

Site Status

DK004

Aalborg, , Denmark

Site Status

DK001

Frederiksberg, , Denmark

Site Status

Site DK002

Glostrup Municipality, , Denmark

Site Status

DK003

Odense, , Denmark

Site Status

FI005

Kokkola, , Finland

Site Status

FI001

Kuopio, , Finland

Site Status

FI003

Lahti, , Finland

Site Status

DE005

Bad Nauheim, , Germany

Site Status

DE014

Berlin, , Germany

Site Status

DE018

Berlin, , Germany

Site Status

DE011

Bochum, , Germany

Site Status

DE015

Böhlen, , Germany

Site Status

DE007

Dresden, , Germany

Site Status

DE016

Essen, , Germany

Site Status

DE001

Hamburg, , Germany

Site Status

DE006

Hamburg, , Germany

Site Status

DE008

Hanover, , Germany

Site Status

DE002

Leipzig, , Germany

Site Status

DE019

Leipzig, , Germany

Site Status

DE009

Mosbach, , Germany

Site Status

DE004

Munich, , Germany

Site Status

DE013

Rodgau, , Germany

Site Status

DE017

Wiesbaden, , Germany

Site Status

HU010

Baja, , Hungary

Site Status

HU008

Békéscsaba, , Hungary

Site Status

HU011

Budapest, , Hungary

Site Status

HU015

Budapest, , Hungary

Site Status

HU005

Budapest, , Hungary

Site Status

HU012

Budapest, , Hungary

Site Status

HU003

Kecskemét, , Hungary

Site Status

HU002

Kiskunfélegyháza, , Hungary

Site Status

HU001

Makó, , Hungary

Site Status

HU009

Nagykanizsa, , Hungary

Site Status

HU014

Nyíregyháza, , Hungary

Site Status

HU004

Szekszárd, , Hungary

Site Status

NL003

Almere Stad, , Netherlands

Site Status

NL002

Eindhoven, , Netherlands

Site Status

NL005

Tiel, , Netherlands

Site Status

PL002

Elblag, , Poland

Site Status

PL015

Gdynia, , Poland

Site Status

PL006

Gdynia, , Poland

Site Status

PL001

Katowice, , Poland

Site Status

PL014

Katowice, , Poland

Site Status

PL008

Krakow, , Poland

Site Status

PL013

Krakow, , Poland

Site Status

PL011

Krakow, , Poland

Site Status

PL009

Lublin, , Poland

Site Status

PL016

Poznan, , Poland

Site Status

PL018

Poznan, , Poland

Site Status

PL012

Warsaw, , Poland

Site Status

PL004

Warsaw, , Poland

Site Status

PL010

Wroclaw, , Poland

Site Status

PL017

Wroclaw, , Poland

Site Status

PL005

Zgierz, , Poland

Site Status

ES004

A Coruña, , Spain

Site Status

ES002

Barcelona, , Spain

Site Status

ES006

Barcelona, , Spain

Site Status

ES001

Madrid, , Spain

Site Status

ES013

Madrid, , Spain

Site Status

ES008

Málaga, , Spain

Site Status

ES003

Oviedo, , Spain

Site Status

ES011

Oviedo, , Spain

Site Status

ES005

Santiago de Compostela, , Spain

Site Status

ES007

Seville, , Spain

Site Status

SE001

Skene, , Sweden

Site Status

SE002

Stockholm, , Sweden

Site Status

SE004

Vällingby, , Sweden

Site Status

GB002

Liverpool, , United Kingdom

Site Status

GB005

London, , United Kingdom

Site Status

GB003

Manchester, , United Kingdom

Site Status

GB004

Plymouth, , United Kingdom

Site Status

Countries

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Austria Belgium Denmark Finland Germany Hungary Netherlands Poland Spain Sweden United Kingdom

Other Identifiers

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2012-001920-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KF6005/06

Identifier Type: -

Identifier Source: org_study_id

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