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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022556-23 | EudraCT Number | ||
| KF6005/03 | Other Identifier | Sponsor |
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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Matching Placebo | Placebo Comparator | Once daily oral administration of matching placebo for 4 weeks. |
|
| 75 µg GRT6005 | Experimental | Once daily oral administration of GRT6005 for 4 weeks. |
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| 200 µg GRT6005 | Experimental | Once daily oral administration of GRT6005 for 4 weeks. |
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| 400 µg GRT6005 | Experimental | Once daily oral administration of GRT6005 for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matching Placebo | Drug | 2 capsules of matching placebo once a day, in the morning, for a total of 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the pain intensity scores during the last week of the 4-week treatment period | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks | |
| Change from baseline in quality of health as measured by Short Form-12 Health Survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacek Olas, MD | Specjalistyczne Centrum Medyczne NZOZ NOWOMED, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 3604 | Linz | 4021 | Austria | |||
| Site 3605 |
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| GRT6005 | Drug | 2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days |
|
| GRT6005 | Drug | 2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days |
|
| GRT6005 | Drug | 2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days |
|
| 4 weeks |
| Response measured in percentage change of pain intensity since baseline | 4 weeks |
| Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking | 4 weeks |
| Patient's Global Impression of Change (PGIC) | 4 weeks |
| Clinician's Global Impression of Change (CGIC) | 4 weeks |
| Weekly current pain intensity changes from baseline | 4 weeks |
| Rescue medication use | 4 weeks |
| Quality of Life EuroQoL-5 Dimension score, change from baseline | 4 weeks |
| Clinical Opioid Withdrawal Scale | 4 weeks |
| Plasma concentration | 4 weeks |
| Discontinuation from study due to treatment related adverse events | 4 weeks |
| Time to withdrawal from study | 4 weeks |
| Senftenberg |
| 3541 |
| Austria |
| Site 3603 | Vienna | 1090 | Austria |
| Site 3602 | Vienna | 1100 | Austria |
| Site 3601 | Vienna | 1130 | Austria |
| Site 3203 | Bialystok | 15-337 | Poland |
| Site 3202 | Elblag | 82-300 | Poland |
| Site 3208 | Gdynia | 81-834 | Poland |
| Site 3206 | Krakow | 30-349 | Poland |
| Site 3207 | Lublin | 20-605 | Poland |
| Site 3210 | Szczecin | 71-252 | Poland |
| Site 3201 | Torun | 87-100 | Poland |
| Site 3211 | Warsaw | 02-730 | Poland |
| Site 3204 | Warsaw | Poland |
| Site 3205 | Wroclaw | 50-088 | Poland |
| Site 3213 | Włoszczowa | 29-100 | Poland |
| Site 3303 | A Coruña | 15006 | Spain |
| Site 3305 | Barcelona | 08028 | Spain |
| Site 3302 | Barcelona | 08034 | Spain |
| Site 3312 | Málaga | 29009 | Spain |
| Site 3308 | Mérida | 06800 | Spain |
| Site 3310 | Oviedo | 33009 | Spain |
| Site 3311 | Petrel | 03610 | Spain |
| Site 3304 | Santiago de Compostela | 15705 | Spain |
| Site 3306 | Seville | 41009 | Spain |
| Site 3313 | Torrelavega | 39300 | Spain |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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