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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
207
2 capsules of matching placebo once a day, in the morning, for a total of 28 days
2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days
2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days
Site 3604
Linz, Austria
Site 3605
Senftenberg, Austria
Change from baseline in the pain intensity scores during the last week of the 4-week treatment period
Time frame: 4 weeks
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days
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
...and 16 more locations
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