The purpose of this phase 2, randomised, double-blind, placebo controlled, parallel group, multicentre study is to investigate the efficacy, safety, tolerability and pharmacokinetics of a compound ONO-4474 in patients with moderate to severe pain due to osteoarthritis of the knee following 4 weeks of oral administration of ONO-4474.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Change from baseline in mean daily average index knee pain while walking
Time frame: Week 4
Safety profile assessed by adverse events, vital signs, laboratory tests, 12-lead electrocardiograms (ECG), physical examination
Time frame: From baseline to study completion, an average of 6 weeks
Safety of ONO-4474 as assessed by C-SSRS (evaluation of suicidal ideation and behavior)
Time frame: From baseline to study completion, an average of 6 weeks
Safety of ONO-4474 as assessed by neurological examination
Time frame: From baseline to study completion, an average of 6 weeks
Change from baseline in mean daily average index knee pain while walking
Time frame: Week 1, Week 2, Week 3 and Weeks 1-4
Change from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain, stiffness and physical function scores
Time frame: Week 1, Week 2, Week 4 and Weeks 1-4
Change from baseline in overall WOMAC score
Time frame: Week 1, Week 2, Week 4 and Weeks 1-4
Change from baseline in mean daily average index knee pain
Time frame: Week 1, Week 2, Week 3, Week 4 and Weeks 1-4
Change from baseline in Patient Global Assessment
Time frame: Week 1, Week 2, Week 4 and Weeks 1-4
Improvement score in Clinical Global Impression
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site
Aalborg, Denmark
Investigational Site
Frederiksberg, Denmark
Investigational Site 4504
Odense, Denmark
Investigational Site
Balatonfüred, Hungary
Investigational Site
Budapest, Hungary
Investigational Site
Eger, Hungary
Investigational Site
Kistarcsa, Hungary
Investigational Site
Mezőkövesd, Hungary
Investigational Site
Szolnok, Hungary
Investigational Site 4808
Bialystok, Poland
...and 37 more locations
Time frame: Week 1, Week 2, Week 4 and Weeks 1-4
Change from baseline in: EuroQoL EQ-5D-5L
Time frame: Week 4
Use of rescue medication as total number of tablets taken
Time frame: Week 1, Week 2, Week 3, Week 4
Time to first rescue medication use
Time frame: Week 4
Pharmacokinetics of ONO-4474 in plasma: Ctrough of ONO-4474
Time frame: Week 1, Week 2 and Week 4