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Glycosaminoglycan (GAG) Analog

Pentosan Polysulfate Sodium Injections for Osteoarthritis

Phase 2 & 3
Recruiting
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
Participant must be >= 18 years of age inclusive, at the time of signing the informed consent.
Clinical diagnosis of OA in the index knee by American College of Rheumatology criteria 1986 criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up stage 1: day 1, 15 and 39 - pre-dose and 2, 4, and 6 hours. pre-dose on days 4, 8, 11, 18, 22, 25, 29, 32 and 36
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Study Summary

This trial will test the effectiveness of pentosan polysulfate sodium injections compared to placebo injections in reducing knee pain and improving function in people with osteoarthritis.

Who is the study for?
Adults with knee osteoarthritis pain unresponsive to standard treatments, who have a BMI of 18-35 kg/m2 and can give informed consent. They must not be using certain medications or have conditions that could interfere with the study, such as recent surgery, other joint diseases, or severe allergies.Check my eligibility
What is being tested?
The trial is testing if injections of Pentosan Polysulfate Sodium (PPS) are better than placebo at reducing knee pain in osteoarthritis. Participants will receive either PPS once or twice weekly, or a placebo for six weeks and will visit the clinic twice weekly during treatment.See study design
What are the potential side effects?
Possible side effects from PPS may include bleeding issues due to its blood-thinning properties, gastrointestinal problems like stomach upset, allergic reactions for those sensitive to heparin-like drugs, liver enzyme changes, and potential hypersensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with osteoarthritis in my knee.
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My knee arthritis is confirmed by X-ray to be moderate to severe.
Select...
Painkillers like acetaminophen don't work for me or I can't take them.
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Painkillers like ibuprofen haven’t helped my pain or I can't take them.
Select...
My knee pain scores between 4 to 10 and hurts when I walk or climb stairs.
Select...
I agree to follow the study's birth control requirements.
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I can sign and agree to follow the study's rules.
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I am 18 years old or older.
Select...
I have been diagnosed with osteoarthritis in my knee.
Select...
My knee arthritis is confirmed by X-ray to be moderate to severe.
Select...
Painkillers like ibuprofen haven’t helped my pain or I can't take them.
Select...
My knee pain scores between 4 to 10 and hurts when I walk or climb stairs.
Select...
I agree to stop taking NSAIDs and pain medications except acetaminophen 2 weeks before the study starts until it ends.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stage 1: day 1, 15 and 39 - pre-dose and 2, 4, and 6 hours. pre-dose on days 4, 8, 11, 18, 22, 25, 29, 32 and 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and stage 1: day 1, 15 and 39 - pre-dose and 2, 4, and 6 hours. pre-dose on days 4, 8, 11, 18, 22, 25, 29, 32 and 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knee
Secondary outcome measures
Key secondary: Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index
Key secondary: Change from baseline at Day 84 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index
Key secondary: Change from baseline at Day 84 in knee pain as assessed by the average pain subscale score of the WOMAC NRS 3.1 Index
+19 more
Other outcome measures
Exploratory: Change in bone shape on MRI from baseline at Day 168
Magnetic Resonance Imaging
Exploratory: Change in joint space width on MRI from baseline at Day 168
+10 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

4Treatment groups
Experimental Treatment
Placebo Group
Group I: PPS Twice WeeklyExperimental Treatment1 Intervention
Pentosan Polysulfate Sodium (PPS) twice weekly for 6 weeks
Group II: PPS Once WeeklyExperimental Treatment2 Interventions
Pentosan Polysulfate Sodium (PPS) + placebo once weekly for 6 weeks
Group III: PPS Fixed Dose Once WeeklyExperimental Treatment2 Interventions
Pentosan Polysulfate Sodium (PPS) Fixed dose (100mg,150mg, or 180mg) once weekly + placebo once weekly for 6 weeks
Group IV: PlaceboPlacebo Group1 Intervention
Placebo twice weekly for 6 weeks

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

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 Polysulfate Sodium (Glycosaminoglycan (GAG) Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04809376 — Phase 2 & 3
Osteoarthritis Research Study Groups: PPS Twice Weekly, PPS Once Weekly, PPS Fixed Dose Once Weekly, Placebo
Osteoarthritis Clinical Trial 2023: Pentosan Polysulfate Sodium Highlights & Side Effects. Trial Name: NCT04809376 — Phase 2 & 3
Pentosan Polysulfate Sodium (Glycosaminoglycan (GAG) Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04809376 — Phase 2 & 3
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04809376 — Phase 2 & 3

Frequently Asked Questions

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

How many individuals are allowed to take part in this experiment at one time?

"In order to maintain the validity of the study, 938 patients that meet the pre-determined inclusion criteria must enroll. These individuals can visit different study sites, such as Kaplan Medical Research in Las Vegas, Nevada and Alliance for Multispecialty Research - Knoxville in Knoxville, Tennessee."

Answered by AI

Could you please summarize the findings of other scientific research studies that have used Pentosan Polysulfate Sodium?

"There are two clinical trials underway that are investigating Pentosan Polysulfate Sodium. Of those two trials, one is in Phase 3. Most of the studies for Pentosan Polysulfate Sodium are based in Maroubra, New South Wales, but there are a total of 39 locations running trials for this treatment."

Answered by AI

Are people still being sought for this experiment?

"The trial is still recruiting patients, as of 3/31/2022, according to the listing on clinicaltrials.gov. The listing was created on 10/19/2021."

Answered by AI

Does this clinical trial test a new treatment?

"Currently, there are 2 ongoing trials for Pentosan Polysulfate Sodium in 31 cities across 2 countries. The earliest trial began in 2021 and was sponsored by Paradigm Biopharmaceuticals USA (INC). 938 patients participated in the Phase 2 & 3 drug approval stage. 2 trials have been completed since 2021."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
California
Arizona
Other
How old are they?
18 - 65
65+
What site did they apply to?
Biosolutions Clinical Research Center
Northwestern University Feinberg School of Medicine
Providence Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
1
3+

What questions have other patients asked about this trial?

What kind of therapy is involved? Medication?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

pain relief money from study. Looking for a better outcome. I have used pentosin in my horses with great results.
PatientReceived no prior treatments
I have tried injections and I’m not getting any relief in my left knee. My left knee has been bothering me for sometime and I think this process will help me get rid of the pain.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 1 Day
Most responsive sites:
  1. Fiel Family and Sports Medicine: < 24 hours
  2. Providence Clinical Research: < 24 hours
~188 spots leftby Oct 2024