A Phase II Study to evaluate efficacy, safety, tolerability and pharmacokinetics of ONO-4474 in patients with pain due to osteoarthritis of the knee
- Conditions
- Osteoarthritic PainMedDRA version: 19.0Level: LLTClassification code 10073925Term: Generalised osteoarthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2016-002675-97-HU
- Lead Sponsor
- Ono Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br>Investigate the effects of ONO-4474 on functional health status and quality of life<br>Investigate the use of rescue medication<br>Evaluate the safety and tolerability of ONO-4474<br>Evaluate the PK of ONO-4474<br>;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 Outcome Measures
Name Time Method