Osteoarthritis, Knee Clinical Trial
Official title:
An Observational Follow-up Study to Investigate the Duration of Treatment Effect With Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain
The purpose of this study is to measure the duration of treatment effect with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adult participants with knee osteoarthritis (OA) pain. The study duration will be up to 34 weeks. Participants who completed pDay 162 of Study PARA_OA_002 (i.e. did not discontinue/withdraw prematurely from the parent study) will be invited to participate.
This is an observational study to determine duration of treatment effect and assess long-term safety up to 52 weeks post PPS use for 6 weeks in parent study (PARA_OA_002). The duration of treatment effect will be evaluated by the OMERACT-OARSI responder criteria for knee OA. Eligible participants will be enrolled in Study PARA_OA_006 at the completion of the parent study PARA_OA_002. There will be no intervention in this observational study. Participants will attend screening (visit 1), three phone visits at 8, 16, and 24 weeks, and an EOS (end of study) visit 34 weeks at the site, a total of 5 visits. Participants questionnaires include WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) NRS 3.1 Index, PGIC (Patients Global Impression of Change), WPAI (Work Productivity and Activity Impairment) and quality of life SF-36. ;
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