Knee osteoarthritis pain
Conditions
Brief summary
Change from baseline at Day 56 in knee pain as assessed by the average pain subscale score of the Western Ontario and McMaster Universities (Osteoarthritis Index) (WOMAC®) Numeric Rating Scale (NRS) 3.1 Index., Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC® NRS 3.1 Index for EMA/MHRA, function will be included as a co-primary endpoint, but still tested in hierarchical order).
Detailed description
Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC® NRS 3.1 Index for EMA/MHRA, function will be included as a co-primary endpoint, but still tested in hierarchical order).Function will be a key secondary in the United States, Change from baseline at Day 84 in knee pain as assessed by the average pain subscale score of the WOMAC® NRS 3.1 Index., Change from baseline at Day 84 in function as assessed by the average functional subscale score of the WOMAC® NRS 3.1 Index.
Interventions
Sponsors
Paradigm Biopharmaceuticals (USA) Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline at Day 56 in knee pain as assessed by the average pain subscale score of the Western Ontario and McMaster Universities (Osteoarthritis Index) (WOMAC®) Numeric Rating Scale (NRS) 3.1 Index., Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC® NRS 3.1 Index for EMA/MHRA, function will be included as a co-primary endpoint, but still tested in hierarchical order). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC® NRS 3.1 Index for EMA/MHRA, function will be included as a co-primary endpoint, but still tested in hierarchical order).Function will be a key secondary in the United States, Change from baseline at Day 84 in knee pain as assessed by the average pain subscale score of the WOMAC® NRS 3.1 Index., Change from baseline at Day 84 in function as assessed by the average functional subscale score of the WOMAC® NRS 3.1 Index. | — |
Countries
Belgium, Czechia, Poland
Outcome results
None listed