Osteoarthritis of the Hip
Conditions
Interventions
Sponsors
Sagawa Kenji
Ono Pharmaceutical Co.,LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients diagnosed with hip OA - Patients who have had pain in the target hip due to OA for more than 6 months prior to the date of consent
Exclusion criteria
Exclusion criteria: - Patients who have pain in the lower back and lower limbs other than the primary disease that exceeds a certain level during the screening period (7 days before the subject enrollment day) - Patients who have undergone surgical procedures, including arthroscopy, on the lower limbs and lower back other than the target hip within 6 months prior to the screening test day (excluding joint fluid aspiration). Additionally, patients whose postoperative condition may affect the evaluation of OA in the target hip even after 6 months are excluded - Patients who have undergone surgical procedures, including arthroscopy, on the target hip (excluding joint fluid aspiration) or who have received PRP therapy on the target hip within one year prior to the screening test day - Patients who have received intra-articular injections of corticosteroids, Joyclu, or Synvisc into the pain site due to the primary disease within 180 days prior to the screening test day, or intra-articular injections of HA products (such as Artz Dispo) into the pain site due to the primary disease within 28 days prior to the screening test day
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