Low Back PainPhase 2NCT01725087
Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.
A Phase 2 study testing Low Dose GRT6005, Medium Dose GRT6005 and High Dose GRT6005 in people with Low Back Pain, run by Tris Pharma, Inc. at 79 sites in 11 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Low Dose GRT6005, Medium Dose GRT6005 and High Dose GRT6005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,089 participants
- Where
- 79 sitesin 11 countries
- Study dates
- Nov 2012to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
79 sites in 11 countries.
79 sites in 11 countries
Germany16 sites
DE005
Bad Nauheim, 61231
DE014
Berlin, 10117
DE018
Berlin, 13125
DE011
Bochum, 44787
DE015
Böhlen, 04564
DE007
Dresden, 01069
DE016
Essen, 45355
DE001
Hamburg, 22415
DE006
Hamburg, 22767
DE008
Hanover, 30159
DE002
Leipzig, 04103
DE019
Leipzig
DE009
Mosbach, 74821
DE004
Munich, 80333
DE013
Rodgau, 63110
DE017
Wiesbaden, 65185
Poland16 sites
PL002
Elblag, 82-300
PL015
Gdynia, 81-338
PL006
Gdynia, 81-384
PL001
Katowice, 40-040
PL014
Katowice, 40-954
PL008
Krakow, 30-510
PL013
Krakow, 30-510
PL011
Krakow, 31-159
PL009
Lublin, 20-605
PL016
Poznan, 60-773
PL018
Poznan, 61-397
PL012
Warsaw, 01-868
PL004
Warsaw, 62-3832
PL010
Wroclaw, 51-162
PL017
Wroclaw, 53-114
PL005
Zgierz, 95-100
Hungary12 sites
HU010
Baja, 6500
HU008
Békéscsaba
HU011
Budapest, 1036
HU015
Budapest, 1084
HU005
Budapest, 1113
HU012
Budapest, 8800
HU003
Kecskemét, 6000
HU002
Kiskunfélegyháza, 6100
HU001
Makó, 6900
HU009
Nagykanizsa, 8800
HU014
Nyíregyháza, 4400
HU004
Szekszárd, 7100
Spain10 sites
ES004
A Coruña, 15006
ES002
Barcelona, 08540
ES006
Barcelona, 8023
ES001
Madrid, 28046
ES013
Madrid, 28050
ES008
Málaga, 29009
ES003
Oviedo, 33009
ES011
Oviedo, 33013
ES005
Santiago de Compostela, 15705
ES007
Seville, 41071
Austria5 sites
AT003
Senftenberg, 3541
AT004
Vienna, 1060
AT001
Vienna, 1090
AT005
Vienna, 1100
AT006
Vienna, 1100
Denmark4 sites
DK004
Aalborg, 9100
DK001
Frederiksberg, 2000
Site DK002
Glostrup Municipality, 2600
DK003
Odense, 5000
United Kingdom4 sites
GB002
Liverpool, L22 0LG
GB005
London, SE1 7EH
GB003
Manchester, M15 6SX
GB004
Plymouth, PL6 8DH
Netherlands3 sites
NL003
Almere Stad, 1311RL
NL002
Eindhoven, 5623EJ
NL005
Tiel, 4002 WP
About this study
Official title: 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.
- Conditions
- Low Back Pain
- Being tested
- Matching Placebo, Low Dose GRT6005, Medium Dose GRT6005, High Dose GRT6005, Tapentadol
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matching PlaceboDrug
Low Dose GRT6005Drug
Medium Dose GRT6005Drug
High Dose GRT6005Drug
TapentadolDrug
| Study group | Role | What they receive |
|---|---|---|
| Matching Placebo | Placebo comparator | Twice daily oral administration of matching placebo for 14 weeks Receives: Drug: Matching Placebo |
| Low Dose GRT6005 | Experimental | Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks. Receives: Drug: Low Dose GRT6005 |
| Medium Dose GRT6005 | Experimental | Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks. Receives: Drug: Medium Dose GRT6005 |
| High Dose GRT6005 | Experimental | Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks. Receives: Drug: High Dose GRT6005 |
| Tapentadol | Active comparator | Twice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks. Receives: Drug: Tapentadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to End of Treatment (Week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Study Director, Study chair, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725087
- Sponsor's protocol ID
- KF6005/06
- Other IDs
- 2012-001920-36
- Status last verified
- Jul 2021
- First submitted
- 8 Nov 2012
- Last updated
- 15 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain.
- ClinicalTrials.gov ID
- NCT01725087
- Acronym / sponsor ID
- KF6005/06
- Conditions
- Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,089 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Matching Placebo | Placebo comparator | Drug: Matching PlaceboTwice daily oral administration of matching placebo for 14 weeks |
| Low Dose GRT6005 | Experimental | Drug: Low Dose GRT6005Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks. |
| Medium Dose GRT6005 | Experimental | Drug: Medium Dose GRT6005Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks. |
| High Dose GRT6005 | Experimental | Drug: High Dose GRT6005Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks. |
| Tapentadol | Active comparator | Drug: TapentadolTwice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matching Placebo | Drug | Matching Placebo |
| Low Dose GRT6005 | Drug | Low Dose GRT6005 |
| Medium Dose GRT6005 | Drug | Medium Dose GRT6005 |
| High Dose GRT6005 | Drug | High Dose GRT6005 |
| Tapentadol | Drug | Tapentadol |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study chair
Grünenthal GmbH
79 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low Dose GRT6005, Medium Dose GRT6005 and High Dose GRT6005 in people with Low Back Pain, run by Tris Pharma, Inc. at 79 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in Germany, Poland, Hungary, Spain, Austria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.