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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
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
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
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major surgery recently and do not plan any during the study.
Select...
I am planning to have total knee reconstruction during the study.
Select...
I am not currently in the hospital and do not plan to be during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (parent study) pday1, weeks 8, 16, 24 and 34
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (parent study) pday1, weeks 8, 16, 24 and 34
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 moreOther 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 moreTrial 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
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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
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Eligibility Criteria:
This trial includes the following eligibility 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.You are not able to have an MRI scan due to a medical condition or reason.I can sign and agree to follow the study's rules.I agree to use only paracetamol or topical pain relief if needed.
Research Study Groups:
This trial has the following groups:- Group 1: Pentosan Polysulfate Sodium
- Group 2: Placebo
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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