PPS Injections for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byThomas Schnitzer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Paradigm Biopharmaceuticals USA (INC)

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Thomas Schnitzer

Principal Investigator

Northwestern University Feinberg School of Medicine

Eligibility Criteria

Adults with knee osteoarthritis pain who completed a previous study (PARA_OA_002) without early withdrawal can join. They must consent to the trial's rules and agree to use only paracetamol or topical analgesics for additional pain relief, avoiding topical NSAIDs.

Inclusion Criteria

I can sign and agree to follow the study's rules.

I agree to use only paracetamol or topical pain relief if needed.

Participants who completed Day 168 of Study PARA_OA_002 (ie, did not discontinue/withdrew prematurely from the parent study).

Exclusion Criteria

I have not had major surgery recently and do not plan any during the study.

I am planning to have total knee reconstruction during the study.

I am not currently in the hospital and do not plan to be during the study.

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Treatment Details

Interventions

Pentosan Polysulphate Sodium (Other)
Placebo (Sodium Chloride Injection, 0.9%) (Other)
Subcutaneous Injections (Other)

Trial OverviewThe trial is testing if injections of Pentosan Polysulfate Sodium (PPS) are effective in treating knee OA pain compared to placebo injections. Participants will receive treatments twice weekly for up to 6 weeks, with the total study lasting up to 80 weeks.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Placebo for 6 weeks

Group II: Pentosan Polysulfate SodiumExperimental Treatment1 Intervention

Pentosan Polysulfate Sodium (PPS) at Dose and frequency selected in Stage 1 of Parent Study for 6 weeks