Moderate to severe pain associated with Osteoarthritis of the knee
Conditions
Brief summary
Incidence of treatment-emergent adverse events (TEAEs). Incidence of TEAEs leading to discontinuation.
Detailed description
Incidence of TEAEs representing structural changes of the knee joint as visualized by the imaging methods (X-ray and/or magnetic resonance imaging [MRI])., Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function and pain subscale score for the index and the non-index (where applicable) knee., Change in QoL as assessed by questionnaires EQ-5D-5L and SF-36.
Interventions
DRUGRTX-GRT7039
DRUGNaropin® 5 mg/ml Injektionslösung
Sponsors
Gruenenthal GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs). Incidence of TEAEs leading to discontinuation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of TEAEs representing structural changes of the knee joint as visualized by the imaging methods (X-ray and/or magnetic resonance imaging [MRI])., Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function and pain subscale score for the index and the non-index (where applicable) knee., Change in QoL as assessed by questionnaires EQ-5D-5L and SF-36. | — |
Countries
Bulgaria, Poland, Romania
Outcome results
None listed