← Back to Search

Other

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
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Agrees to continue use of paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy, if required.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, days 11, 25, 39, 56, 84 112, 140 and 168
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can sign and agree to follow the study's rules.
Select...
I agree to use only paracetamol or topical pain relief if needed.
Select...
I agree to use only paracetamol or topical pain relief if needed.
Select...
I can sign and agree to follow the study's rules.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, days 11, 25, 39, 56, 84 112, 140 and 168
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, days 11, 25, 39, 56, 84 112, 140 and 168 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time from initial response in the parent study (PARA_OA_002) to loss of OMERACT-OARSI response through Follow-up Week 28 (Part 1)
Alopecia
Secondary outcome measures
Change from baseline at Treatment Days 11, 25, 39, 56, 84, 112, 140, and 168 in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36)
Change from baseline at Treatment Days 11, 25, 39, 84, 112, 140 and 168 as assessed by the average overall score of the WOMAC® NRS 3.1 Index.
Change from baseline at Treatment Days 11, 25, 39, 84, 112, 140 and 168 in function as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index.
+22 more
Other outcome measures
Change in bone shape on MRI from baseline of the parent study at Week 28 and 80
Change in cartilage volume on MRI from baseline of the parent study at Week 28 and 80
Change in joint space width on MRI from baseline of the parent study at Week 28 and 80
+4 more

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pentosan Polysulfate SodiumExperimental Treatment1 Intervention
Pentosan Polysulfate Sodium (PPS) at Dose and frequency selected in Stage 1 of Parent Study for 6 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo 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
~193 spots leftby Oct 2024