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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725087
• Other study ID #: KF6005/06
• Secondary ID: 2012-001920-36
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2021
• Source: Tris Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1089
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Matching Placebo

• Low Dose GRT6005

• Medium Dose GRT6005

• High Dose GRT6005

• Tapentadol

Locations

Country	Name	City	State
Austria	AT003	Senftenberg
Austria	AT001	Wien
Austria	AT004	Wien
Austria	AT005	Wien
Austria	AT006	Wien
Belgium	BE001	Bruxelles
Belgium	BE002	Edegem
Belgium	BE004	Genk
Denmark	DK004	Aalborg
Denmark	DK001	Frederiksberg
Denmark	Site DK002	Glostrup
Denmark	DK003	Odense
Finland	FI005	Kokkola
Finland	FI001	Kuopio
Finland	FI003	Lahti
Germany	DE005	Bad Nauheim
Germany	DE014	Berlin
Germany	DE018	Berlin
Germany	DE011	Bochum
Germany	DE015	Böhlen
Germany	DE007	Dresden
Germany	DE016	Essen
Germany	DE001	Hamburg
Germany	DE006	Hamburg
Germany	DE008	Hannover
Germany	DE002	Leipzig
Germany	DE019	Leipzig
Germany	DE009	Mosbach
Germany	DE004	Munich
Germany	DE013	Rodgau
Germany	DE017	Wiesbaden
Hungary	HU010	Baja
Hungary	HU008	Békéscsaba
Hungary	HU005	Budapest
Hungary	HU011	Budapest
Hungary	HU012	Budapest
Hungary	HU015	Budapest
Hungary	HU003	Kecskemet
Hungary	HU002	Kiskunfélegyháza
Hungary	HU001	Mako
Hungary	HU009	Nagykanizsa
Hungary	HU014	Nyiregyhaza
Hungary	HU004	Szekszárd
Netherlands	NL003	Almere
Netherlands	NL002	Eindhoven
Netherlands	NL005	Tiel
Poland	PL002	Elblag
Poland	PL006	Gdynia
Poland	PL015	Gdynia
Poland	PL001	Katowice
Poland	PL014	Katowice
Poland	PL008	Krakow
Poland	PL011	Krakow
Poland	PL013	Krakow
Poland	PL009	Lublin
Poland	PL016	Poznan
Poland	PL018	Poznan
Poland	PL004	Warszawa
Poland	PL012	Warszawa
Poland	PL010	Wroclaw
Poland	PL017	Wroclaw
Poland	PL005	Zgierz
Spain	ES002	Barcelona
Spain	ES006	Barcelona
Spain	ES004	La Coruna
Spain	ES001	Madrid
Spain	ES013	Madrid
Spain	ES008	Málaga
Spain	ES003	Oviedo
Spain	ES011	Oviedo
Spain	ES005	Santiago de Compostela
Spain	ES007	Sevilla
Sweden	SE001	Skene
Sweden	SE002	Stockholm
Sweden	SE004	Vällingby
United Kingdom	GB002	Liverpool
United Kingdom	GB005	London
United Kingdom	GB003	Manchester
United Kingdom	GB004	Plymouth

Sponsors (2)

Lead Sponsor	Collaborator
Tris Pharma, Inc.	Forest Laboratories

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)