Osteoarthritis of the Knee
Conditions
Interventions
Sponsors
Sagawa Kenji
Ono Pharmaceutical Co.,LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients diagnosed with knee OA according to the criteria of the American College of Rheumatology (ACR) on the screening test day: - Patients who have pain in the target knee - Patients who have osteophyte formation in the target knee on X-ray imaging - Patients who meet at least one of the following criteria: - Age > 50 years - Duration of morning stiffness < 30 minutes - Presence of crepitus - Patients who have had pain in the target knee due to OA for more than one year prior to the date of consent - Patients with KL grade 2 or 3 on standing anteroposterior X-ray imaging taken on the screening test day - Patients with WOMAC pain subscore and 50-foot walk test score of 50 mm or more and 90 mm or less in the target knee on both the screening test day and the subject enrollment day - Patients with WOMAC pain subscore and 50-foot walk test score of 30 mm or less in the opposite knee to the target knee on both the screening test day and the subject enrollment day
Exclusion criteria
Exclusion criteria: - Patients whose OA is secondary to trauma or other diseases - Patients who have symptomatic OA in the lower limbs other than the knee joint (foot OA, hip OA, etc.) on the screening test day or subject enrollment day - Patients who have pain due to other primary diseases that may affect the evaluation of the target OA in the lower limbs on the screening test day or subject enrollment day - Patients who have undergone surgical procedures on the target knee joint or invasive procedures such as joint lavage or PRP therapy on the target knee joint within one year prior to the screening test day (excluding joint fluid aspiration) - Patients who have undergone surgical procedures or invasive procedures such as joint lavage on the lower limbs other than the target knee joint within one year prior to the screening test day (excluding joint fluid aspiration) - Patients who have received intra-articular injections of corticosteroids, Joyclu, or Synvisc in either knee within 180 days prior to the screening test day, or intra-articular injections of sodium hyaluronate (HA) products (such as Artz Dispo) in either knee within 28 days prior to the start of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC pain subscore Change from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| - WOMAC physical funtion subscore - Patient global evaluation - OMERACT-OARSI responder - Daily pain by subject diary - WOMAC stiffness subscore - WOMAC total score - Physician global evaluation - SF-36 physical component score - Use of acetaminophen rescue medication | — |
Contacts
Public ContactYuji Nobuoka
Seikagaku Corporation
Outcome results
None listed