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PPS Injections for Knee Osteoarthritis

Phase 3
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (parent study) pday1, weeks 8, 16, 24 and 34
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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
+7 more
Other outcome measures
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

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
938 Total Patients Enrolled
1 Trials studying Osteoarthritis
938 Patients Enrolled for Osteoarthritis
Thomas SchnitzerPrincipal InvestigatorNorthwestern University Feinberg School of Medicine
1 Previous Clinical Trials
938 Total Patients Enrolled
1 Trials studying Osteoarthritis
938 Patients Enrolled for Osteoarthritis

Media Library

Pentosan Polysulphate Sodium (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04814719 — Phase 3
Osteoarthritis Research Study Groups: Pentosan Polysulfate Sodium, Placebo
Osteoarthritis Clinical Trial 2023: Pentosan Polysulphate Sodium Highlights & Side Effects. Trial Name: NCT04814719 — Phase 3
Pentosan Polysulphate Sodium (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04814719 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any places still available for patients who want to participate in this research?

"Sadly, this specific study is not currently taking on any new patients. This is according to the clinicaltrials.gov website, which also reports that the trial was first posted on December 24th, 2021 and was last edited on March 22nd, 2021. However, there are 722 other studies that are recruiting patients as we speak."

Answered by AI

What is the desired outcome of this experiment?

"The primary outcome of this trial is to assess the time from initial response in the parent study to loss of OMERACT-OARSI response through Follow-up Week 28 (Part 1). Secondary outcomes include Change from baseline at Treatment Days 11, 25, 39, 84, 112, 140 and 168 in stiffness as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index. which is defined as Change from baseline of stiffness following treatment/re-treatment. WOMAC: The WOMAC stiffness sub-scale is a 2-item questionnaire used to assess the amount of stiffness experienced due to"

Answered by AI

Are there any other scientific papers which explore Pentosan Polysulphate Sodium?

"There are 2 ongoing studies and 2 in Phase 3 researching Pentosan Polysulphate Sodium. The majority of the 39 locations for these trials are based in Maroubra, New South Wales."

Answered by AI

Are there any know dangers or side-effects to taking Pentosan Polysulphate Sodium?

"There is some evidence from previous trials to suggest that Pentosan Polysulphate Sodium is effective and safe."

Answered by AI

Has a study like this been undertaken before?

"Research on Pentosan Polysulphate Sodium began in 2021 with the first clinical trial sponsored by Paradigm Biopharmaceuticals USA (INC). Since the initial study involving 938 people, the drug has been approved for Phase 2 & 3. Currently, there are 2 active studies being conducted across 31 cities in 2 countries."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
An Observational Follow-up Study to Evaluate Duration of Treatment Effect of Pentosan Polysulfate Sodium in Participants With Knee Osteoarthritis Pain
2023. "An Observational Follow-up Study to Evaluate Duration of Treatment Effect of Pentosan Polysulfate Sodium in Participants With Knee Osteoarthritis Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04814719.
All > Osteoarthritis > Knee Osteoarthritis
~52 spots leftby Dec 2024
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