Clinical Study of Artz in the Treatment of Knee Osteoarthritis
Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, randomized, open-label, parallel-arm phase IV clinical study, for
which a total of 300 patients with mild to moderate knee osteoarthritis will be enrolled. In
the first 4 weeks (run-in period), the subjects will receive on-demand treatment with
Diclofenac Sodium Sustained Release Tablets (DICL-SR) 75mg, quaque die（QD）. After the run-in
period, the subjects, if their knee pain has not worsened to a level requiring surgical
treatment, will be randomized to two groups in 1:1 ratio: one group receiving Artz® via
intra-articular injection (once weekly, for 5 consecutive weeks) in combination with DICL-SR
75mg,quaque die（QD）, for 12 consecutive weeks on demand. The other group receiving DICL-SR
75mg alone,quaque die（QD）, for 12 consecutive weeks on demand. DICL-SR 75mg quaque die（QD）
may be administered to the subjects of both groups on demand as long as they have a knee
pain. If the knee pain has disappeared, this drug may be withdrawn. However, if the pain
occurs again and requires treatment, oral administration of DICL-SR may be resumed. A subject
is allowed to withdraw from this study prematurely if unable to tolerate the adverse effects.
A total of 8 visits have been scheduled for this study, including Visit 1/screening period
(Week -4), Visit 2/baseline (Week 0), Visit 3 (Week 1), Visit 4 (Week 2), Visit 5 (Week 3),
Visit 6 (Week 4), Visit 7 (Week 8) and Visit 8 (Week 12).
A total of 300 subjects will participate in this study at 6 to 8 centers in China, and
patient enrollment is expected to take up to 12 months.