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PPS Injections for Knee Osteoarthritis

N/A
Waitlist Available
Led By Thomas Schnitzer
Research Sponsored by Paradigm Biopharmaceuticals USA (INC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Major surgery or anticipated surgery during the study.
Plan for total knee reconstruction in affected knee(s) during the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (parent study) pday1, weeks 8, 16, 24 and 34
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing the effectiveness of a drug called pentosan polysulfate sodium (PPS) for treating knee pain caused by osteoarthritis. The study will last up to 80 weeks, and participants will receive either PPS injections or placebo injections.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects aren't listed here, PPS may cause reactions at injection sites, gastrointestinal issues, headache, dizziness or allergic reactions. Placebo effects could include discomfort from injections.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery recently and do not plan any during the study.
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I am planning to have total knee reconstruction during the study.
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I am not currently in the hospital and do not plan to be during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (parent study) pday1, weeks 8, 16, 24 and 34
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (parent study) pday1, weeks 8, 16, 24 and 34 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the duration of treatment effect of PPS in participants with OA pain
Secondary study objectives
Change from baseline of the parent study in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36)
Change from baseline of the parent study in Work Productivity and Activity Impairment (WPAI) questionnaire.
Overall score WOMAC NRS 3.1in participants with knee OA
+6 more
Other study objectives
Change in bone shape on MRI and whether these correlate with clinical outcomes
Change in joint space width on MRI
Change in joint space width on X-ray
+4 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

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

Find a Location

Who is running the clinical trial?

Paradigm Biopharmaceuticals USA (INC)Lead Sponsor
1 Previous Clinical Trials
602 Total Patients Enrolled
1 Trials studying Osteoarthritis
602 Patients Enrolled for Osteoarthritis
Thomas SchnitzerPrincipal InvestigatorNorthwestern University Feinberg School of Medicine
1 Previous Clinical Trials
602 Total Patients Enrolled
1 Trials studying Osteoarthritis
602 Patients Enrolled for Osteoarthritis

Media Library

Pentosan Polysulphate Sodium (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04814719 — N/A
Osteoarthritis Research Study Groups: Pentosan Polysulfate Sodium, Placebo
Osteoarthritis Clinical Trial 2023: Pentosan Polysulphate Sodium Highlights & Side Effects. Trial Name: NCT04814719 — N/A
Pentosan Polysulphate Sodium (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04814719 — N/A
~0 spots leftby Dec 2024
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