A randomized, two-arm, placebo-controlled, participant and investigator-blinded study investigating the efficacy, safety and tolerability of DFV890 in patients with symptomatic knee osteoarthritis

Conditions

Knee Osteoarthritis

Brief summary

Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale at week 12

Detailed description

Change from baseline in synovitis activity level measured from K-trans by DCE-MRI at week 12, Systemic and local Adverse Events and Serious Adverse Events, Electrocardiograms (ECGs) parameters, Vital signs, Hematology, blood chemistry and urinalysis., Change from baseline in serum high sensitivity C-reactive protein level and absolute neutrophil counts at week 2,4,8 and 12, Plasma samples to quantify concentrations of DFV890 at various time points (week 2 and week 12) and to derive PK parameters in plasma (including but not limited to Cmax, AUC last, AUC0-12h, and Cthrough), Change from baseline in KOOS sub-scales (other symptoms, function in daily living, function in sport and recreation, knee-related quality of life) at weeks 2, 4, 8 and 12, Change in KOOS pain subscale from baseline to weeks 2, 4, 8 and 12, Change in numeric rating scale (NRS) for pain from baseline to weeks 2, 4, 8 and 12

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGParacetamol/Codeine phosphate hemihydrate Accord 500 mg/30 mg tablets

DRUGPARACETAMOL

DRUGDFV890

DRUGPlacebo to DFV890 10mg

DRUGPlacebo to DFV890 25mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale at week 12	—

Secondary

Measure	Time frame
Change from baseline in synovitis activity level measured from K-trans by DCE-MRI at week 12, Systemic and local Adverse Events and Serious Adverse Events, Electrocardiograms (ECGs) parameters, Vital signs, Hematology, blood chemistry and urinalysis., Change from baseline in serum high sensitivity C-reactive protein level and absolute neutrophil counts at week 2,4,8 and 12, Plasma samples to quantify concentrations of DFV890 at various time points (week 2 and week 12) and to derive PK parameters in plasma (including but not limited to Cmax, AUC last, AUC0-12h, and Cthrough), Change from baseline in KOOS sub-scales (other symptoms, function in daily living, function in sport and recreation, knee-related quality of life) at weeks 2, 4, 8 and 12, Change in KOOS pain subscale from baseline to weeks 2, 4, 8 and 12, Change in numeric rating scale (NRS) for pain from baseline to weeks 2, 4, 8 and 12	—

Measure

Time frame

Change from baseline in synovitis activity level measured from K-trans by DCE-MRI at week 12, Systemic and local Adverse Events and Serious Adverse Events, Electrocardiograms (ECGs) parameters, Vital signs, Hematology, blood chemistry and urinalysis., Change from baseline in serum high sensitivity C-reactive protein level and absolute neutrophil counts at week 2,4,8 and 12, Plasma samples to quantify concentrations of DFV890 at various time points (week 2 and week 12) and to derive PK parameters in plasma (including but not limited to Cmax, AUC last, AUC0-12h, and Cthrough), Change from baseline in KOOS sub-scales (other symptoms, function in daily living, function in sport and recreation, knee-related quality of life) at weeks 2, 4, 8 and 12, Change in KOOS pain subscale from baseline to weeks 2, 4, 8 and 12, Change in numeric rating scale (NRS) for pain from baseline to weeks 2, 4, 8 and 12

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Countries

Czechia, Germany, Hungary, Romania, Spain

Outcome results

None listed