Your session is about to expire
← Back to Search
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
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 belowSelect...
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 acetaminophen don't work for me or I can't take them.
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 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 weeks3 visits
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
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
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 moreOther 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 moreTrial 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
133 Total Patients Enrolled
1 Trials studying Osteoarthritis
133 Patients Enrolled for Osteoarthritis
Thomas SchnitzerPrincipal InvestigatorNorthwestern University Feinberg School of Medicine
1 Previous Clinical Trials
133 Total Patients Enrolled
1 Trials studying Osteoarthritis
133 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction in the past to PPS, heparin, or similar medications.My knee pain scores between 4 to 10 and hurts when I walk or climb stairs.My knee arthritis is confirmed by X-ray to be moderate to severe.Painkillers like ibuprofen haven’t helped my pain or I can't take them.I have had a stomach or intestinal ulcer, or signs of bleeding in my digestive tract in the last year.I agree to follow the study's rules for birth control.I agree to stop taking NSAIDs and pain medications except acetaminophen 2 weeks before the study starts until it ends.I have a history of low platelet counts due to an immune response.You have multiple allergies or atopic diseases like eczema, asthma, or allergic rhinitis that can cause severe hypersensitivity.I am allergic to or cannot take Tetracosactide.I have had pituitary gland treatment with radiation or surgery through the nose within the last year.I have not had any cancer except for basal cell carcinoma in the last 5 years.You have or had a condition called autoimmune polyglandular syndrome.I am taking blood thinners or anti-clotting medications, but not more than 100 mg of aspirin daily.I have been treated with PPS before.I have not used opioids in the last 6 weeks.I have taken steroids for OA or other reasons within the last 8 weeks.I haven't had steroid or hyaluronic acid knee injections in the last 24 weeks.My blood pressure is high, but it has been stable for at least a month.I am mostly confined to bed or a wheelchair and cannot care for myself.I am allergic to or cannot have Gadolinium contrast agents.I have used heparin or had cardiac bypass surgery or a clotting disorder.I have not had major surgery recently nor do I plan any during the study.I am 18 years old or older.I have been diagnosed with osteoarthritis in my knee.I agree to use only acetaminophen or topical pain relievers if needed.I have not taken Megestrol Acetate in the last 6 weeks.I am not taking any medications that change my sodium or potassium levels.My knee X-rays show no severe misalignment, chondrocalcinosis, other joint diseases, bone diseases, tumors, or fractures.My knee pain scores between 4 to 10 and hurts when I walk or climb stairs.I have not taken bisphosphonates in the last 12 weeks.I haven't used strong immune system altering drugs recently, except for minor hydrocortisone cream use.I have not changed my non-drug knee OA treatments in the last 2 weeks and won't change them during the study.I have not changed my medication for chronic conditions in the last 60 days.I do not have severe pain from other conditions that could affect my osteoarthritis pain assessment.I haven't taken any supplements that affect blood clotting in the last 2 weeks.I can sign and agree to follow the study's rules.Painkillers like ibuprofen haven’t helped my pain or I can't take them.My knee arthritis is confirmed by X-ray to be moderate to severe.I have not taken biotin in the 6 weeks before starting the trial.I do not have active hepatitis B or C, or uncontrolled HIV.I haven't taken dehydroepiandrosterone sulfates in the last 6 weeks.I have not used denosumab or iloprost in the last 12 weeks.I agree to follow the study's birth control requirements.I have not had knee surgery or injury to my knee in the last year.I am not in the hospital nor do I plan to be during the study.I can sign and agree to follow the study's rules.I have a history of bleeding easily without taking blood thinners.I haven't taken any long-term oral steroids or cortisol blockers in the last 12 weeks.You have pain and stiffness in your knee, and your score on a pain scale is between 4 and 10.I have used a knee brace on my affected knee in the last 2 weeks.I have had osteonecrosis or a fracture due to osteoporosis.Your body weight is within a healthy range based on your height.I am 18 years old or older.I am planning to have total knee reconstruction during the study.I have been diagnosed with osteoarthritis in my knee.You cannot have an MRI scan for medical reasons.My knee pain from arthritis hasn't improved with treatment for over 6 months.Painkillers like acetaminophen don't work for me or I can't take them.I have no history of diseases like rheumatoid arthritis affecting my joints.Painkillers like acetaminophen don't work for me or I can't take them.
Research Study Groups:
This trial has the following groups:- Group 1: PPS Twice Weekly
- Group 2: PPS Once Weekly
- Group 3: PPS Fixed Dose Once Weekly
- Group 4: Placebo
Awards:
This trial has 2 awards, including:- 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.
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.
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?
Fiel Family and Sports Medicine
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+
Why did patients apply to this trial?
I'm always in pain. pain relief money from study. Looking for a better outcome.
PatientReceived 2+ prior treatments
I have used pentosin in my horses with great results. I have tried injections and I’m not getting any relief in my left knee.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
What kind of therapy is involved? Medication?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 1 Day
Most responsive sites:
- Fiel Family and Sports Medicine: < 24 hours
- Providence Clinical Research: < 24 hours
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger