Osteoarthritic Pain MedDRA version: 19.0 Level: LLT Classification code 10073925 Term: Generalised osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Product Code: ONO-4474
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not applicable
CAS Number: unspecified
Current Sponsor code: ONO-4474TS
Other descriptive name: ONO-4474TS
Concentra
Sponsors
Ono Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female (of non-childbearing potential) aged between 40 – 75 years inclusive at the time of signing the informed consent form 2. Symptomatic OA of the knee for =3 months diagnosed prior to screening as per American College of Rheumatology clinical criteria 3. Radiographic evidence of tibiofemoral OA of index knee (Kellgren-Lawrence grade 2-3), as confirmed at screening 4. Moderate to severe index knee pain due to OA requiring use of analgesic medication 5. Willing to discontinue use of all analgesic medication (aside from rescue medication) during the study Other inclusion criteria will also be applied. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 210 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Presence of, or history of, a. any inflammatory arthritis (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondylarthropathy, septic arthritis, previous diagnosis of pseudogout in target joint with proven crystals on joint aspiration or elevated C-Reactive Protein (CRP) at time of knee arthritis flare) b. RPOA, osteonecrosis, osteoporotic fracture or any other painful joint disease other than OA c. Secondary causes of OA; other rheumatologic or musculoskeletal conditions (e.g., rheumatoid arthritis, fibromyalgia, septic arthritis, congenital abnormality) 2. Orthopaedic surgery of a lower extremity or any major surgery within the previous 6 months prior to Visit 1 or has plans for surgical intervention during the study 3. Symptomatic hip OA 4. A history of partial or complete joint replacement surgery in the index knee at any time or anticipating knee surgery during the study period 5. Significant knee injury or any knee surgery (including arthroscopy) in the index knee within 6 months prior to screening 6. Patients with uncontrolled diabetes Other exclusion criteria will also be applied.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the effects of ONO-4474 on walking pain;Secondary Objective: Investigate the effects of ONO-4474 on knee pain, stiffness and function Investigate the effects of ONO-4474 on functional health status and quality of life Investigate the use of rescue medication Evaluate the safety and tolerability of ONO-4474 Evaluate the PK of ONO-4474 ;Primary end point(s): Change from baseline to Week 4 in mean daily average index knee pain while walking (24h recall);Timepoint(s) of evaluation of this end point: Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline to: • Weeks 1, 2 and 3, and over 4 weeks in mean daily average index knee pain while walking (24h recall) • Weeks 1, 2 and 4, and over 4 weeks in WOMAC pain, stiffness and physical function scores (48h recall) • Weeks 1, 2 and 4, and over 4 weeks in overall WOMAC score (48h recall) • Weeks 1, 2, 3 and 4, and over 4 weeks in mean daily average index knee pain (24h recall) Change from baseline to Weeks 1, 2 and 4, and over 4 weeks in Patient Global Assessment (PGA) Improvement score on Weeks 1, 2 and 4, and over 4 weeks in Clinical Global Impression (CGI) Change from baseline to Week 4 in EuroQoL EQ-5D-5L Use of rescue medication as a total number of tablets taken at Weeks 1, 2, 3 and 4 Time to first rescue medication use Safety profile as assessed by physical examination (including weight and height [height screening only]), vital signs, 12-lead electrocardiogram (ECG), safety laboratory evaluations, C-SSRS, adverse events, neurological examination Ctrough of ONO-4474 in plasma collected pre-dose at Visits 4, 5 and 7 ;Timepoint(s) of evaluation of this end point: Weeks 1, 2, 3, 4 and over 4 weeks | — |
Countries
Denmark, Hungary, Poland, Spain
Contacts
Public ContactClinical Trial Information Desk
Ono Pharma UK Ltd
Outcome results
None listed