Osteoarthritis of the KneePhase 2NCT01357837
Assessment of GRT6005 in Painful Osteoarthritis of the Knee
A Phase 2 study testing GRT6005 in people with Osteoarthritis of the Knee, run by Tris Pharma, Inc. at 26 sites in 3 countries.
Trial summary
The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- GRT6005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 26 sitesin 3 countries
- Study dates
- May 2011to Dec 2011
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- painful Osteoarthritis of the knee based on American College of Rheumatology Criteria
- signed informed consent
- on stable analgesic medications for painful osteoarthritis with regular analgesic intake for at least 3 months
- pain intensity score of 4 or greater on the 11-point numeric rating scale (where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine").
Who cannot join
- Substance Abuse
- Significant cardiac disease
- Presence of risk factors for Torsades de Pointes and chronic severe cardiac disease
- History of seizure disorder
- Chronic gastrointestinal disease
- Conditions that contribute and confound to the assessment of pain
Show all 13Show fewer
- Surgery or painful procedure during or within 3 months of enrollment
- Cancer
- Subjects with impaired renal function
- Subjects with impaired hepatic function
- Female subjects who are breastfeeding
- History of chronic hepatitis B or C or human immunodeficiency virus infection, or presence of acute hepatitis A, B, or C within the past 3 months.
- Clinically relevant history of hypersensitivity or allergy to paracetamol, opioids or the excipients.
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
Poland11 sites
Site 3203
Bialystok, 15-337
Site 3202
Elblag, 82-300
Site 3208
Gdynia, 81-834
Site 3206
Krakow, 30-349
Site 3207
Lublin, 20-605
Site 3210
Szczecin, 71-252
Site 3201
Torun, 87-100
Site 3211
Warsaw, 02-730
Site 3204
Warsaw
Site 3213
Włoszczowa, 29-100
Site 3205
Wroclaw, 50-088
Spain10 sites
Site 3303
A Coruña, 15006
Site 3305
Barcelona, 08028
Site 3302
Barcelona, 08034
Site 3312
Málaga, 29009
Site 3308
Mérida, 06800
Site 3310
Oviedo, 33009
Site 3311
Petrel, 03610
Site 3304
Santiago de Compostela, 15705
Site 3306
Seville, 41009
Site 3313
Torrelavega, 39300
Austria5 sites
Site 3604
Linz, 4021
Site 3605
Senftenberg, 3541
Site 3603
Vienna, 1090
Site 3602
Vienna, 1100
Site 3601
Vienna, 1130
About this study
Official title: A Randomized 4 Week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee
The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.
Read the detailed description
The purpose of this study is to evaluate the safety, tolerability and efficacy of 3 doses of GRT6005 taken once daily for 4 weeks in outpatients with moderate-to-severe painful osteoarthritis of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Matching Placebo, GRT6005
- Keywords
- Osteoarthritis, knee, Analgesia, Pain, Painful
- Medical subject headings
- Osteoarthritis, Knee, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matching PlaceboDrug
2 capsules of matching placebo once a day, in the morning, for a total of 28 days
GRT6005Drug
2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days
GRT6005Drug
2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days
GRT6005Drug
2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days
| Study group | Role | What they receive |
|---|---|---|
| Matching Placebo | Placebo comparator | Once daily oral administration of matching placebo for 4 weeks. Receives: Drug: Matching Placebo |
| 75 µg GRT6005 | Experimental | Once daily oral administration of GRT6005 for 4 weeks. Receives: Drug: GRT6005 |
| 200 µg GRT6005 | Experimental | Once daily oral administration of GRT6005 for 4 weeks. Receives: Drug: GRT6005 |
| 400 µg GRT6005 | Experimental | Once daily oral administration of GRT6005 for 4 weeks. Receives: Drug: GRT6005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the pain intensity scores during the last week of the 4-week treatment period
Measured: 4 weeks
Secondary outcomes (13)
Change from baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the 4 week treatment period
Measured: 4 weeks
Change from baseline in quality of health as measured by Short Form-12 Health Survey
Measured: 4 weeks
Response measured in percentage change of pain intensity since baseline
Measured: 4 weeks
Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking
Measured: 4 weeks
Patient's Global Impression of Change (PGIC)
Measured: 4 weeks
Clinician's Global Impression of Change (CGIC)
Measured: 4 weeks
Weekly current pain intensity changes from baseline
Measured: 4 weeks
Rescue medication use
Measured: 4 weeks
Quality of Life EuroQoL-5 Dimension score, change from baseline
Measured: 4 weeks
Clinical Opioid Withdrawal Scale
Measured: 4 weeks
Plasma concentration
Measured: 4 weeks
Discontinuation from study due to treatment related adverse events
Measured: 4 weeks
Time to withdrawal from study
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Jacek Olas, MD, Principal investigator, Specjalistyczne Centrum Medyczne NZOZ NOWOMED,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357837
- Sponsor's protocol ID
- 116918
- Other IDs
- 2010-022556-23, KF6005/03
- Status last verified
- Jul 2021
- First submitted
- 19 May 2011
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- 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
- A Randomized 4 Week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee
- ClinicalTrials.gov ID
- NCT01357837
- Acronym / sponsor ID
- 116918
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, knee, Analgesia, Pain, Painful
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 May 2011 (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 the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.
Detailed description
The purpose of this study is to evaluate the safety, tolerability and efficacy of 3 doses of GRT6005 taken once daily for 4 weeks in outpatients with moderate-to-severe painful osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Matching Placebo | Placebo comparator | Drug: Matching PlaceboOnce daily oral administration of matching placebo for 4 weeks. |
| 75 µg GRT6005 | Experimental | Drug: GRT6005Once daily oral administration of GRT6005 for 4 weeks. |
| 200 µg GRT6005 | Experimental | Drug: GRT6005Once daily oral administration of GRT6005 for 4 weeks. |
| 400 µg GRT6005 | Experimental | Drug: GRT6005Once daily oral administration of GRT6005 for 4 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- painful Osteoarthritis of the knee based on American College of Rheumatology Criteria
- signed informed consent
- on stable analgesic medications for painful osteoarthritis with regular analgesic intake for at least 3 months
- pain intensity score of 4 or greater on the 11-point numeric rating scale (where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine").
Key exclusion criteria (13 listed)
- Substance Abuse
- Significant cardiac disease
- Presence of risk factors for Torsades de Pointes and chronic severe cardiac disease
- History of seizure disorder
- Chronic gastrointestinal disease
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 Placebo2 capsules of matching placebo once a day, in the morning, for a total of 28 days | Drug | Matching Placebo |
| GRT60052 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days | Drug | 75 µg GRT6005 |
| GRT60052 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days | Drug | 200 µg GRT6005 |
| GRT60052 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days | Drug | 400 µg GRT6005 |
Primary outcome
Change from baseline in the pain intensity scores during the last week of the 4-week treatment period
Time frame: 4 weeks
13 secondary outcomes
Change from baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the 4 week treatment period
Time frame: 4 weeks
Change from baseline in quality of health as measured by Short Form-12 Health Survey
Time frame: 4 weeks
Response measured in percentage change of pain intensity since baseline
Time frame: 4 weeks
Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking
Time frame: 4 weeks
Patient's Global Impression of Change (PGIC)
Time frame: 4 weeks
Clinician's Global Impression of Change (CGIC)
Time frame: 4 weeks
Weekly current pain intensity changes from baseline
Time frame: 4 weeks
Rescue medication use
Time frame: 4 weeks
Quality of Life EuroQoL-5 Dimension score, change from baseline
Time frame: 4 weeks
Clinical Opioid Withdrawal Scale
Time frame: 4 weeks
Plasma concentration
Time frame: 4 weeks
Discontinuation from study due to treatment related adverse events
Time frame: 4 weeks
Time to withdrawal from study
Time frame: 4 weeks
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.
Jacek Olas, MD principal investigator
Specjalistyczne Centrum Medyczne NZOZ NOWOMED,
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRT6005 in people with Osteoarthritis of the Knee, run by Tris Pharma, Inc. at 26 sites in 3 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 26 sites in Poland, Spain, Austria. 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?
Change from baseline in the pain intensity scores during the last week of the 4-week treatment period (time frame: 4 weeks). 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.