A Study to Investigate The Duration of Treatment Effect and Re-treatment With Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain

Summary

Participation Requirements

Description

This is a follow-up extension study to determine duration of treatment effect and assess long-term safety and response to re-treatment with PPS in participants with knee OA pain who completed the parent study study (PARA_OA_002). Study PARA_OA_006 consists of Follow-up Part 1 and Part 2 and a Treatm...

This is a follow-up extension study to determine duration of treatment effect and assess long-term safety and response to re-treatment with PPS in participants with knee OA pain who completed the parent study study (PARA_OA_002). Study PARA_OA_006 consists of Follow-up Part 1 and Part 2 and a Treatment Part Eligible participants will be enrolled in Study PARA_OA_006 at the completion of the parent study and will enter the 6-month Follow-up Part 1. At the end of Follow-up Part 1, participants will begin the Treatment Part of the study, continue to Follow-up Part 2, or end the study depending on the treatment received in the parent study, their response to treatment during the parent study, and/or their response status at the end of the Follow-up Part 1 Participants in the Treatment Part will be administered twice weekly subcutaneous (SC) injections for 6 weeks: The PPS dose regimen will be 1 of the 3 dose regimens evaluated in Stage 1 of the parent study and selected by the independent data monitoring committee (DMC). Placebo will be 0.9% w/v sodium chloride injection. The maximum duration of study participation will be approximately: 28 weeks for participants who complete Follow-up Part 1 and are not eligible to continue to Follow-up Part 2 or the Treatment Part 56 weeks for participants who complete Follow-up Part 1 and the Treatment Part 68 weeks for participants who complete Follow-up Part 1, Follow-up Part 2 up to Week 40, and the Treatment Part 80 weeks for participants who complete Follow-up Parts 1 and 2 or Follow-up Part 1, Follow-up Part 2 up to Week 52 and the Treatment Part

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