Osteoarthritis
Conditions
Sponsors
SEIKAGAKU CORPORATION
ONO PHARMACEUTICAL CO., LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Shoulder OA Subject who has primary or secondary shoulder osteoarthritis caused by following disease. Rotator cuff tear(Grade 4 on the radiographic classification of massive rotator cuff tears) Shoulder OA resulting from trauma Subject who has grade 2 or 3 score on the K-L grading scale based on a bilateral anteroposterior(AP)or scapular Y view x-ray of the target shoulder at the screening visit. Elbow OA Subject who has primary elbow OA or secondary elbow OA resulting from trauma. Subject who has a grade 2 or 3 score on the K-L grading scale based on a anteroposterior(AP)or lateral x-ray of the target elbow at the screening visit. Hip OA Subject who has primary or secondary hip OA resulting from acetabular dysplasia. Subject who has a grade "Early" or "Advanced" on the Japanese Orthopaedic Assosiation OA Disease Classification based on a anteroposterior(AP)x-ray of the target hip at the screening visit. Ankle OA Subject who has primary ankle OA or secondary ankle OA resulting from trauma. Subject who meets at least one following criteria at the screening visit. Has stage 2 or 3 on the Varus Type Ankle OA Disease Classification based on a anteroposterior(AP)x-ray of the target ankle. Has stage 1 on that classification and has definite osteophyte at the edge of lower tibia or talus based on a AP or lateral x-ray of the terget ankle. Common inclusion criteria Subject who has OA pain in the target joint for greater than or equal to 6 months prior to the time of informed consent. Is willing and able to complete daily pain diary during the study and is able to read and understand study instructions. Subjects who are willing to discontinue pain medication except as permitted per protocol from the start date of screening to the end of Week 24 after the first injection(using acetaminophen as a rescue medication is permitted for breakthrough pain control. however, using acetaminophen is prohibitted for the 2 days priot to each study visit).
Exclusion criteria
Exclusion criteria: Subjects who have pain which would interfere with the evaluation of the target OA evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Daily pain diary Change from baseline in daily pain diary over 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Shoulder36(shoulder) PREE-J(elbow) WOMAC(hip) SAFE-Q(ankle) The incidence of adverse events | — |
Countries
Japan
Outcome results
None listed