knee synovitis and osteoarthritis
Conditions
Brief summary
Change from Baseline at W4 in the weekly average of TK daily pain intensity using the WOMAC Pain subscore
Detailed description
Change from Baseline at W2, W6, W8, W10 and W12: - Weekly average of TK daily pain (WOMAC Pain), Change from Baseline at W2, W4, W8 and W12: - NRS (0-10) pain in a nominated pain aggravating activity - WOMAC subscores and total score - Patient Global Assessment of OA (PGA-OA), % of OMERACT-OARSI Responders at W2, W4, W8 and W12, Incidence and severity of TEAEs during the trial, Absolute values and changes from Baseline in: - Clinical laboratory assessments (hematology, chemistry, and urinalysis) - Vital signs (systolic and diastolic blood pressure [BP], pulse rate,), Directed physical examination
Interventions
Sponsors
4moving Biotech
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline at W4 in the weekly average of TK daily pain intensity using the WOMAC Pain subscore | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline at W2, W6, W8, W10 and W12: - Weekly average of TK daily pain (WOMAC Pain), Change from Baseline at W2, W4, W8 and W12: - NRS (0-10) pain in a nominated pain aggravating activity - WOMAC subscores and total score - Patient Global Assessment of OA (PGA-OA), % of OMERACT-OARSI Responders at W2, W4, W8 and W12, Incidence and severity of TEAEs during the trial, Absolute values and changes from Baseline in: - Clinical laboratory assessments (hematology, chemistry, and urinalysis) - Vital signs (systolic and diastolic blood pressure [BP], pulse rate,), Directed physical examination | — |
Countries
Denmark, France, Poland, Spain
Outcome results
None listed