Actively Recruiting
A Phase 3, Randomised, Double-Blind, Placebo-Controlled Multi-Centre Study to Evaluate the Treatment Effect of Pentosan Polysulfate Sodium Compared to Placebo in Participants With Knee Osteoarthritis Pain
Led by Paradigm Biopharmaceuticals Ltd. · Updated on 2026-05-08
466
Participants Needed
56
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adults experiencing knee osteoarthritis (OA) pain. This randomized, double-blind, placebo-controlled phase 3 study aims to measure changes in pain and function over a treatment and follow-up period. The study involves participants with knee OA who have not responded to certain existing therapies, and the research is sponsored by Paradigm Biopharmaceuticals Ltd. Participants will be randomly assigned to receive either PPS or a placebo via subcutaneous injections twice weekly for 6 weeks. The study timeline includes a 7-week screening period, a 6-week treatment period, and a 52-week follow-up. Approximately 466 adults will be enrolled, and an interim analysis will occur after half of the participants complete Day 112, with final analyses conducted after all complete Day 404. Throughout the study, participants will visit the study center twice weekly during treatment and approximately every 4 to 6 weeks during follow-up. They will undergo assessments of knee pain using daily pain scores, function evaluations with the WOMAC index, quality of life questionnaires, and imaging tests including MRI and X-rays. Researchers will monitor safety through adverse event tracking and clinical tests. Total participation may last up to 64 weeks.
CONDITIONS
Brief Title
A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of signing informed consent.
- Clinical diagnosis of knee osteoarthritis by American College of Rheumatology 1986 criteria.
- Radiographic confirmation of knee osteoarthritis with Kellgren-Lawrence grade 2, 3, or 4.
- Unresponsive for at least 6 months to at least two different OA therapies, including non-pharmacologic and pharmacologic treatments, or unable to take NSAIDs.
- Average daily pain score between 4 and 9 on a numerical rating scale at screening and baseline.
- No more than one daily pain score of 10 in the week before treatment.
- Body mass index between 18.0 and 39.0 kg/m2.
- Women of childbearing potential and men must agree to use contraception.
- Able to give informed consent and comply with study requirements.
- Completion of at least 11 out of 14 daily pain scores before randomization.
- Stable non-pharmacologic treatment regimen for at least 2 weeks before Day 1 and throughout the study.
- Willing to stop oral and topical NSAIDs and other systemic pain medications except allowed rescue medication.
- Agree to use acetaminophen or topical analgesics (excluding topical NSAIDs) as rescue therapy if needed.
You will not qualify if you...
- History of idiopathic or immune-mediated thrombocytopenia or heparin-induced thrombocytopenia.
- History of major bleeding disorders including haemophilia.
- Active or recent gastric or duodenal ulcer or suspected gastrointestinal bleeding within 12 months.
- Recent cerebral bleeding or brain, spine, or eye surgery within 12 months.
- Spinal anaesthesia within 14 days before Day 1.
- Fibromyalgia, regional pain from nerve compression, or other severe pain disorders affecting assessment.
- Other diseases affecting the knee such as rheumatoid arthritis, gout, lupus, infections, tumours.
- Allergy to pentosan polysulfate sodium, heparin, or similar drugs.
- Multiple severe allergies or atopic diseases.
- Allergy to specific drugs like tetracosactide or gadolinium.
- Unstable or poorly controlled chronic medical conditions requiring recent treatment changes.
- History of pituitary irradiation or recent pituitary surgery.
- Cancer within the past 5 years except basal cell carcinomas.
- Autoimmune polyglandular syndromes.
- Medical or psychological conditions likely to interfere with study compliance.
- Current use of anticoagulants or antiplatelet drugs (except low-dose aspirin).
- Previous treatment with pentosan polysulfate sodium.
- Recent immunosuppressive or immunomodulatory treatments.
- Use of NSAIDs, opioids, glucosamine, chondroitin, bisphosphonates, denosumab, iloprost, or cannabinoids within specified timeframes before Day 1.
- Use of knee brace on the affected knee within 2 weeks before Day 1.
- Recent steroid use or intra-articular injections within specified timeframes.
- Use of stem cells or platelet-rich plasma within 12 months.
- Use of vitamins or supplements affecting blood clotting within 2 weeks before Day 1 (except multivitamins).
- Known heparin exposure within 100 days.
- Use of certain hormonal treatments within specified timeframes.
- Participation in another clinical trial or experimental treatment within 24 weeks or 5 half-lives before Day 1.
- Abnormal lab test results or active infections including hepatitis or uncontrolled HIV.
- Significant knee malalignment or other knee conditions identified by imaging.
- Significant abnormalities on clinical exam or vital signs.
- Uncontrolled high blood pressure.
- Certain eye diseases or findings.
- Low morning cortisol or ACTH levels.
- Electrolyte imbalances.
- Contraindications to MRI.
- Incapacitation limiting self-care.
- Major surgery or planned surgery during the study.
- Hospitalization or planned hospitalization during the study.
- Planned total knee reconstruction during the study.
- Knee surgery or trauma to the affected knee within 1 year before Day 1.
- Recent history of drug or alcohol abuse affecting compliance.
- Employment or family relationship with the sponsor or study personnel.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 7 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive subcutaneous injections of either pentosan polysulfate sodium or placebo twice weekly to manage knee osteoarthritis pain.
Twice-weekly injection visits for 6 weeks
Duration - 52 weeks
Participants are monitored for safety and effectiveness outcomes after treatment ends.
Regular visits up to Day 404 for assessments and monitoring
Trial Site Locations
Total: 56 locations
1
Onyx Clinical Research-Peoria
Peoria, Arizona, United States, 85381
Actively Recruiting
2
Del Sol Research Management, LLC
Tucson, Arizona, United States, 85715
Actively Recruiting
3
Orange County Research Institute
Anaheim, California, United States, 92801
Actively Recruiting
4
Core Healthcare Group
Cerritos, California, United States, 90703
Actively Recruiting
5
Triwest Research Center
Chula Vista, California, United States, 91910
Actively Recruiting
6
Seaside Medical Group
Oceanside, California, United States, 92058
Actively Recruiting
7
Paragon RX Clinical
Santa Ana, California, United States, 92703
Actively Recruiting
8
Encompass Clinical Research
Spring Valley, California, United States, 91978
Actively Recruiting
9
Focus Clinical Research
West Hills, California, United States, 91307
Actively Recruiting
10
Clinical Research of West Florida - Clearwater
Clearwater, Florida, United States, 33765
Actively Recruiting
11
GNP Research
Cooper City, Florida, United States, 33024
Actively Recruiting
12
Arrow Clinical Trials
Daytona Beach, Florida, United States, 32117
Actively Recruiting
13
AGA Clinical Trials
Hialeah, Florida, United States, 33012
Actively Recruiting
14
Evolution Clinical Trials
Miami, Florida, United States, 33122
Actively Recruiting
15
Well Pharma Medical Research
Miami, Florida, United States, 33173
Actively Recruiting
16
K2 Medical Research
Orlando, Florida, United States, 32806
Actively Recruiting
17
Progressive Medical Research
Port Orange, Florida, United States, 32127
Actively Recruiting
18
Phoenix Clinical Research
Tamarac, Florida, United States, 33321
Actively Recruiting
19
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
20
Chicago Clinical Research, Inc
Chicago, Illinois, United States, 60607
Actively Recruiting
21
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
22
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
23
Profound Research
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
24
Insight Research Institute
Flint, Michigan, United States, 48507
Actively Recruiting
25
Rochester Medical Group
Rochester Hills, Michigan, United States, 48307
Actively Recruiting
26
Onyx Clinical Research - Rochester Hills
Troy, Michigan, United States, 48085
Actively Recruiting
27
Physician Research Collaboration
Lincoln, Nebraska, United States, 68516
Actively Recruiting
28
Alpine Healthcare Family Practice
Las Vegas, Nevada, United States, 89109
Actively Recruiting
29
Drug Trials America
Hartsdale, New York, United States, 10530
Actively Recruiting
30
Groth Pain & Spine - Long Island, NY
Mineola, New York, United States, 11501
Actively Recruiting
31
IMA Clinical Research Manhattan
New York, New York, United States, 10036
Actively Recruiting
32
Groth Pain and Spine Management
Smithtown, New York, United States, 11787
Actively Recruiting
33
FutureSearch Trials of Neurology
Austin, Texas, United States, 78731
Actively Recruiting
34
FutureSearch Trials of Dallas
Dallas, Texas, United States, 75251
Actively Recruiting
35
Vilo Research Group
Houston, Texas, United States, 77017
Actively Recruiting
36
DM Clinical Research
Houston, Texas, United States, 77065
Actively Recruiting
37
Clinical Trial Network
Houston, Texas, United States, 77074
Actively Recruiting
38
Epic Clinical Research
Lewisville, Texas, United States, 75057
Actively Recruiting
39
Quality Research Inc.
San Antonio, Texas, United States, 78209
Actively Recruiting
40
Rio Clinical Trials
Ogden, Utah, United States, 84404
Actively Recruiting
41
Canopy Clinical Research-Northern Beaches
Brookvale, New South Wales, Australia, 2100
Actively Recruiting
42
Novatrials
Charlestown, New South Wales, Australia, 2290
Actively Recruiting
43
Canopy Clinical Research - Sutherland Shire
Miranda, New South Wales, Australia, 2228
Actively Recruiting
44
Canopy Clinical Research-Wollongong
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
45
Mater Health Brisbane
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
46
Griffith University
Southport, Queensland, Australia, 4222
Actively Recruiting
47
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
48
Sportsmed
Stepney, South Australia, Australia, 5069
Actively Recruiting
49
Canopy Clinical Research-Altona North
Altona N., Victoria, Australia, 3025
Actively Recruiting
50
Sportsmed Biologic LTD
Box Hill, Victoria, Australia, 3128
Actively Recruiting
51
Clinitrials
Perth, Western Australia, Australia, 6000
Actively Recruiting
52
RK Will Pty Ltd
Victoria Park, Western Australia, Australia, 6100
Actively Recruiting
53
Hong Kong Centre for Clinical Research
Hong Kong, Hong Kong
Actively Recruiting
54
PMSI "Timofei Mosneaga" Republican Clinical Hospital
Chisinau, Moldova, MD2025
Actively Recruiting
55
PMSI Institute of Cardiology
Chisinau, Moldova, MD2025
Actively Recruiting
56
PMSI "Sfanta Treime" Municipal Clinical Hospital
Chisinau, Moldova, MD2068
Actively Recruiting
Research Team
D
Donna Skerrett
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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