Osteoarthritis of the Knee, Osteoarthritis of the Hip
Conditions
Interventions
Subject will be received an intra-articular injection of investigational drug (Gel-One) administered
Sponsors
Sagawa Kenji
Ono Pharmaceutical Co.,LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients diagnosed with knee OA or hip OA based on standing anteroposterior or hip anteroposterior X-ray imaging and symptoms - Patients who have had pain in the target knee or target hip due to OA for more than 12 weeks prior to the date of consent
Exclusion criteria
Exclusion criteria: - Patients who have undergone surgical procedures on the target joint or invasive procedures such as joint lavage or PRP therapy on the target joint within one year prior to the start of screening - Patients who have large osteophytes or significant joint space narrowing on X-ray imaging taken on the screening test day - Patients who have received intra-articular injections of the following drugs into the target site within the specified periods: - Corticosteroids, Joyclu, or Synvisc within 180 days prior to the screening test day - Other drugs (HA products such as Artz Dispo, local anesthetics, etc.) within 7 days prior to the screening test day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Adverse Events - Vital Signs - Clinical Laboratory Evaluation - Target Knee Examination | — |
Secondary
| Measure | Time frame |
|---|---|
| - WOMAC pain subscore - WOMAC physical function subscore - Patient global evaluation - OMERACT-OARSI responder rate - WOMAC stiffness subscore - WOMAC total score - Physician global evaluation - SF-36 - Changes of medications for underlying disease | — |
Contacts
Public ContactYuji Nobuoka
Seikagaku Corporation
Outcome results
None listed