Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium Versus Placebo in Participants With Knee Osteoarthritis Pain

Summary

Participation Requirements

Description

This is a 2-stage, adaptive, randomized, double-blind, placebo-controlled, multicenter study that will evaluate the dose and treatment effect of PPS in participants with knee OA pain. In Stage 1 (dose selection), approximately 468 participants will be randomised 1:1:1:1 to receive 1 of 3 PPS dose re...

This is a 2-stage, adaptive, randomized, double-blind, placebo-controlled, multicenter study that will evaluate the dose and treatment effect of PPS in participants with knee OA pain. In Stage 1 (dose selection), approximately 468 participants will be randomised 1:1:1:1 to receive 1 of 3 PPS dose regimens or placebo for 6 weeks. A minimum of 96 participants (24 within each dose group) will be assigned to the Pharmacokinetic (PK) subset. Participants in Stage 1 will be randomly allocated to receive: 2 mg/kg calculated for ideal body weight (IBW) PPS twice weekly 2 mg/kg IBW PPS once weekly + placebo once weekly 100/150 mg PPS ?65/>65 kg IBW once weekly + placebo once weekly placebo twice weekly In Stage 2, approximately 470 participants will be randomized 1:1 to receive the selected PPS dose regimen or placebo for 6 weeks. Approximately 150 participants (75 per group) will be assigned to the PK subset. Participants in Stage 2 will be randomly allocated to receive: One of the 3 Stage 1 PPS dose regimens selected by the DMC placebo twice weekly The maximum duration for each participant is approximately 28 weeks, which includes: 4-week Screening Period from Day -28 to Day -1 6-week Treatment Period from Day 1 to Day 39 18-week Follow-up Period from Day 40 to Day 168

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