Assessment of GRT6005 in Painful Osteoarthritis of the Knee
NCT ID: NCT01357837
Last Updated: 2021-07-15
Study Results
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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COMPLETED
PHASE2
207 participants
INTERVENTIONAL
2011-05-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Matching Placebo
Once daily oral administration of matching placebo for 4 weeks.
Matching Placebo
2 capsules of matching placebo once a day, in the morning, for a total of 28 days
75 µg GRT6005
Once daily oral administration of GRT6005 for 4 weeks.
GRT6005
2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days
200 µg GRT6005
Once daily oral administration of GRT6005 for 4 weeks.
GRT6005
2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days
400 µg GRT6005
Once daily oral administration of GRT6005 for 4 weeks.
GRT6005
2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days
Interventions
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Matching Placebo
2 capsules of matching placebo once a day, in the morning, for a total of 28 days
GRT6005
2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days
GRT6005
2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days
GRT6005
2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days
Eligibility Criteria
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Inclusion 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").
Exclusion Criteria
* 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
* 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.
40 Years
75 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Tris Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jacek Olas, MD
Role: PRINCIPAL_INVESTIGATOR
Specjalistyczne Centrum Medyczne NZOZ NOWOMED,
Locations
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Site 3604
Linz, , Austria
Site 3605
Senftenberg, , Austria
Site 3603
Vienna, , Austria
Site 3602
Vienna, , Austria
Site 3601
Vienna, , Austria
Site 3203
Bialystok, , Poland
Site 3202
Elblag, , Poland
Site 3208
Gdynia, , Poland
Site 3206
Krakow, , Poland
Site 3207
Lublin, , Poland
Site 3210
Szczecin, , Poland
Site 3201
Torun, , Poland
Site 3211
Warsaw, , Poland
Site 3204
Warsaw, , Poland
Site 3205
Wroclaw, , Poland
Site 3213
Włoszczowa, , Poland
Site 3303
A Coruña, , Spain
Site 3305
Barcelona, , Spain
Site 3302
Barcelona, , Spain
Site 3312
Málaga, , Spain
Site 3308
Mérida, , Spain
Site 3310
Oviedo, , Spain
Site 3311
Petrel, , Spain
Site 3304
Santiago de Compostela, , Spain
Site 3306
Seville, , Spain
Site 3313
Torrelavega, , Spain
Countries
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Other Identifiers
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2010-022556-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KF6005/03
Identifier Type: OTHER
Identifier Source: secondary_id
116918
Identifier Type: -
Identifier Source: org_study_id
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