A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.
NCT ID: NCT06917404
Last Updated: 2025-11-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
466 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-05-29
Study Completion Date
2027-07-31
Brief Summary
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The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee OA pain.
Study details include:
* The study duration will be up to 64 weeks.
* The treatment duration will be 6 weeks.
* The visit frequency will be twice weekly during treatment.
* The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period.
* Approximately 466 participants will be enrolled into this study.
Study details include:
* The study duration will be up to 64 weeks.
* The treatment duration will be 6 weeks.
* The visit frequency will be twice weekly during treatment.
* The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period.
* Approximately 466 participants will be enrolled into this study.
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Detailed Description
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This is a randomised, double-blind, placebo-controlled, multicenter study that will evaluate the dose and treatment effect of PPS in participants with knee OA pain.
Participants will be randomised 1:1 to receive twice-weekly subcutaneous (SC) injections of 2 mg/kg PPS or placebo for 6 weeks.
An interim analysis for a potential early conclusion is planned after approximately 50% of participants complete Day 112.
The primary analysis will be conducted when all participants complete Day 112. A final analysis will be conducted when the last participant reaches Day 404.
The maximum duration for each participant is up to 64 weeks, which includes
* 7-week Screening Period from Day -45 to Day -1
* 6-week Treatment Period from Day 1 to Day 39
* 52-week Follow-up Period from Day 40 to Day 404
Participants will be randomised 1:1 to receive twice-weekly subcutaneous (SC) injections of 2 mg/kg PPS or placebo for 6 weeks.
An interim analysis for a potential early conclusion is planned after approximately 50% of participants complete Day 112.
The primary analysis will be conducted when all participants complete Day 112. A final analysis will be conducted when the last participant reaches Day 404.
The maximum duration for each participant is up to 64 weeks, which includes
* 7-week Screening Period from Day -45 to Day -1
* 6-week Treatment Period from Day 1 to Day 39
* 52-week Follow-up Period from Day 40 to Day 404
Conditions
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Osteoarthritis, Knee
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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PPS
Pentosan polysulfate sodium 2mg/kg twice weekly for 6 weeks
Group Type
ACTIVE_COMPARATOR
Pentosan Polysulfate Sodium twice weekly
Intervention Type
DRUG
Subcutaneous injection, 2 mg/kg twice weekly for 6 weeks
Placebo
Placebo (Sodium Chloride Injection, 0.9%) twice weekly for 6 weeks
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo, subcutaneous injection, twice weekly for 6 weeks
Interventions
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Pentosan Polysulfate Sodium twice weekly
Subcutaneous injection, 2 mg/kg twice weekly for 6 weeks
Intervention Type
DRUG
Placebo
Placebo, subcutaneous injection, twice weekly for 6 weeks
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Participant must be ≥18 years of age inclusive, at the time of signing the informed consent.
2. Clinical diagnosis of OA in the index knee by American College of Rheumatology 1986 criteria.
3. Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-L grade 2, 3, or 4 on standing anterior-posterior X-ray of the index knee.
4. Participant is unresponsive for at least 6 months preceding Screening to any two combinations of OA therapies (one from each A and B) within the last 12 months that include: A.) conservative non-pharmacologic therapy (exercise, weight loss, physical therapy) or simple analgesics (e.g., acetaminophen) and B.) pharmacological treatment (topical or oral NSAIDs \[or cyclooxygenase (COX) inhibitor\], or intra-articular \[IA\] injections), or participant is unable to take NSAIDs because of contraindication or inability to tolerate.
5. Average daily pain (ADP) numerical rating scale (NRS) score of 4-9 in the index knee at Screening.
6. Baseline average weekly ADP NRS score of 4-9 in the index knee in the 7 days prior to randomization.
7. No more than one 24-hr average pain score (0-10 NRS) reported as "10" during the 7 days prior to Day 1.
8. Body mass index of ≥18.0 to ≤39.0 kg/m2.
9. Female subjects of childbearing potential and Male subjects must agree to comply with protocol specified contraceptive requirements
10. 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.
11. Completion of at least 11 out of 14 ADP NRS scores for at least 14 days prior to randomisation.
12. Current non-pharmacologic treatment regimen for knee OA (excluding knee brace) must be stable for at least 2 weeks before Day 1 and remain stable throughout the study. Participant must be willing to abstain from starting a new or changing their non-pharmacologic treatment regimen for the duration of the study.
13. Willing to stop treatment with oral and topical NSAIDs, and all other systemic pain medications (except allowed rescue medication) from 2 weeks before Day 1 to end of study.
14. Agrees to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy if required.
2. Clinical diagnosis of OA in the index knee by American College of Rheumatology 1986 criteria.
3. Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-L grade 2, 3, or 4 on standing anterior-posterior X-ray of the index knee.
4. Participant is unresponsive for at least 6 months preceding Screening to any two combinations of OA therapies (one from each A and B) within the last 12 months that include: A.) conservative non-pharmacologic therapy (exercise, weight loss, physical therapy) or simple analgesics (e.g., acetaminophen) and B.) pharmacological treatment (topical or oral NSAIDs \[or cyclooxygenase (COX) inhibitor\], or intra-articular \[IA\] injections), or participant is unable to take NSAIDs because of contraindication or inability to tolerate.
5. Average daily pain (ADP) numerical rating scale (NRS) score of 4-9 in the index knee at Screening.
6. Baseline average weekly ADP NRS score of 4-9 in the index knee in the 7 days prior to randomization.
7. No more than one 24-hr average pain score (0-10 NRS) reported as "10" during the 7 days prior to Day 1.
8. Body mass index of ≥18.0 to ≤39.0 kg/m2.
9. Female subjects of childbearing potential and Male subjects must agree to comply with protocol specified contraceptive requirements
10. 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.
11. Completion of at least 11 out of 14 ADP NRS scores for at least 14 days prior to randomisation.
12. Current non-pharmacologic treatment regimen for knee OA (excluding knee brace) must be stable for at least 2 weeks before Day 1 and remain stable throughout the study. Participant must be willing to abstain from starting a new or changing their non-pharmacologic treatment regimen for the duration of the study.
13. Willing to stop treatment with oral and topical NSAIDs, and all other systemic pain medications (except allowed rescue medication) from 2 weeks before Day 1 to end of study.
14. Agrees to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy if required.
Exclusion Criteria
1. History of idiopathic or immune-mediated thrombocytopenia including history of HIT with or without thrombosis.
2. History of major bleeding disorders including haemophilia.
3. Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
4. Recent cerebral bleeding or operation on brain, spine, or eyes within 12 months of Day 1.
5. Spinal anaesthesia within 14 days of Day 1.
6. Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy, or other moderate to severe pain disorder that may confound assessments or self-evaluation of the pain associated with osteoarthritis. Participants with a present (current) history of sciatica are not eligible for participation. Participants with a history of sciatica who have been asymptomatic for ≥3 months and who have no evidence of radiculopathy or sciatic neuropathy on thorough neurologic examination are eligible for participation.
7. History of other disease that may involve the index knee, including inflammatory joint disease such as rheumatoid arthritis (RA), seronegative spondyloarthropathy (e.g., ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease-related arthropathy), crystalline disease (e.g., gout), endocrinopathies, metabolic joint diseases, lupus erythematosus, joint infections, Paget's disease, or tumours.
8. History of hypersensitivity to PPS, heparin or heparin-like drugs, or drugs of a similar chemical or pharmacological class.
9. Predisposition to hypersensitivity due to multiple (2 or more) atopic diseases (such as atopic eczema, asthma, and chronic allergic rhinitis and/or rhinoconjunctivitis) or multiple (2 or more) severe allergies.
10. Allergy or contraindication to tetracosactide (Synacthen®), cosyntropin (Cortrosyn®).
11. Allergy or contraindication to gadolinium.
12. Chronic medical conditions including but not limited to those stated below requiring medical regime changes within 60 days before Day 1.
Concurrent unstable peripheral, cardiac, and cerebral vascular disease, poorly controlled chronic obstructive pulmonary disease and asthma, coagulopathies, uncontrolled neurological conditions, active tuberculosis, active infections, symptomatic cardiac arrhythmias, adrenal insufficiency (primary or central), nephrotic syndrome, cirrhosis (Child-Pugh stage B or C), Gilbert syndrome, uncontrolled diabetes, and uncontrolled hypothyroidism or hyperthyroidism, or mental or emotional disorders that preclude reliable study participation.
13. History of pituitary irradiation or recent (within 1 year) history of transsphenoidal surgery.
14. Any cancer within the previous 5 years, except for basal cell carcinomas.
15. History or current autoimmune polyglandular syndromes.
16. Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per the protocol.
17. Current treatment with anticoagulants or antiplatelet drugs within 2 weeks before Day 1, excluding aspirin ≤150 mg/day.
18. Previous treatment with PPS in any form.
19. Current or recent (within 90 days before Day 1) immunosuppressive or immunomodulatory (with immunosuppressive effects) systemic therapy including but not limited to oral, inhaled, intranasal, intra-articular (IA) and topical corticosteroids (occasional use of topical, inhaled or intranasal corticosteroids is acceptable).
20. Use of NSAIDs with 2 weeks before Day 1.
21. Use of opioids within 6 weeks before Day 1.
22. Use of glucosamine or chondroitin within 6 weeks before Day 1.
23. Use of bisphosphonates and denosumab within 12 weeks before Day 1.
24. Use of iloprost within 12 weeks before Day 1.
25. Use of a knee brace on the index knee within 2 weeks before Day 1.
26. Systemic steroids administered intravenously, intramuscularly, or orally for OA or other indications within 8 weeks before Day 1.
27. Intra-articular (IA) injections to the index knee: steroids within 12 weeks before Day 1; hyaluronic acid (HA) or any other IA injections within 24 weeks before Day 1.
28. Stem cells or platelet-rich plasma within 12 months of Day 1.
29. Cannabinoids within 30 days before Day 1.
30. Use of individual vitamins and dietary supplements known to alter haemostasis within 2 weeks before Day 1, including ajoene, birch bark, cayenne, Chinese black tree fungus, cumin, evening primrose oil, feverfew, garlic, ginger, ginkgo biloba, ginseng, grapeseed extract, milk thistle, omega 3 fatty acids, onion extract, St. John's wort, turmeric, vitamins C and E, vitamin K, (multivitamins allowed).
31. Known exposure to heparin within the last 100 days as determined by history of drug use or history of the following medical conditions or interventions: cardiac bypass surgery or thromboembolic disease.
32. Treatment with dehydroepiandrosterone sulfates (DHEA-S) within 6 weeks before Day 1.
33. Chronic use of oral glucocorticoid receptor antagonists or cortisol synthesis inhibitors within 12 weeks before Day 1.
34. Biotin within 72 hours before Screening.
35. Megestrol acetate within 6 weeks before Day 1.
36. Participation in another clinical trial or administration of any IP or experimental product within 24 weeks or 5 half-lives (whichever is longer) before Day 1.
37. Activated partial thromboplastin time \[aPTT\]) \> 36 seconds, platelets \<150,000/μL, or liver enzyme tests (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) ≥ 2 × ULN at Screening.
38. Total bilirubin ≥1.5 ULN.
39. Active or chronic hepatitis B virus, hepatitis C virus, or uncontrolled HIV infection (detectable virus or diagnosis of AIDS); participants with HIV infection must be on chronic suppressive antiviral medication.
40. Evidence of any of the following conditions in any screening imaging: excessive malalignment (≥10 degrees varus or valgus) of the knee, subchondral insufficiency fracture (SIF), osteonecrosis/bone infarct, osteochondritis dissecans, stress or acute fracture, atrophic OA, pathologic fracture, primary or metastatic tumour, infectious arthritis or osteomyelitis, chronic or acute, Charcot's knee joint, synovial chondromatosis, certain posterior root tears of the meniscus, bone contusion, bone marrow oedema syndrome, bone marrow infiltration, gout, severe chondrocalcinosis, other arthropathies (e.g., RA, psoriatic arthritis), systemic metabolic bone disease (e.g., Paget's disease, metastatic calcifications) or other conditions identified by a radiologist or Medical Monitor which may interfere with a participant's assessment of pain.
41. Any clinically significant abnormalities on clinical chemistry, haematology, urinalysis, physical examination, medical history, or vital signs as judged by the Investigator (at Screening).
42. Resting, supine blood pressure (BP) ≥160 mmHg in systolic pressure or ≥100 mmHg in diastolic pressure at Screening. If a participant is found to have uncontrolled and/or untreated significant hypertension at Screening and antihypertensive treatment is initiated, assessment for study eligibility should be deferred until BP and antihypertensive medication have been stable for at least 1 month. For participants with previously diagnosed hypertension, antihypertensive medications must be stable for at least 1 month before Screening.
43. Any macular findings on clinical examination or imaging suggestive of: moderate or advanced dry macular degeneration, geographic atrophy, moderate or advanced myopic degeneration, wet macular degeneration, pattern dystrophy or other pigmentary maculopathy, moderate or severe diabetic or hypertensive retinopathy, recent retinal vascular occlusion, macular hole or advanced epiretinal membrane with associated macular oedema, retinal dystrophy, toxic retinal maculopathy, chronic central serous retinopathy, presence of significant subretinal or intraretinal fluid (OCT finding), presence of vitelliform or vitelliform-like macular changes (OCT and clinical finding), severe maculopathy not otherwise specified.
44. Morning cortisol \<3 μg/dL.
45. Adrenocorticotropic hormone (ACTH) \<10 pg/mL.
46. US/Canada only: Morning cortisol ≥3 μg/dL and \<10 μg/dL and peak cortisol (by ACTH stimulation \[250 μg, IM\] test) \<18 μg/dL at both 30 min and 60 min post stimulation.
47. Current hyperkalaemia and/or hyponatremia.
48. Contraindication to MRI.
49. Largely or wholly incapacitated (e.g., bedridden or confined to a wheelchair, permitting little or no self-care).
50. Major surgery or anticipated surgery during the study.
51. Currently hospitalised or any planned hospitalizations during the study.
52. Plan for total knee reconstruction in affected knee(s) during the study.
53. Knee surgery or trauma to the index knee within 1 year before Day 1.
54. A history of drug or alcohol abuse and/or dependence within the 12 months before Screening that, in the opinion of the Investigator, may affect participant ability to comply with study requirements.
55. An employee of the Sponsor, clinical research organisation(s), or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.
2. History of major bleeding disorders including haemophilia.
3. Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
4. Recent cerebral bleeding or operation on brain, spine, or eyes within 12 months of Day 1.
5. Spinal anaesthesia within 14 days of Day 1.
6. Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy, or other moderate to severe pain disorder that may confound assessments or self-evaluation of the pain associated with osteoarthritis. Participants with a present (current) history of sciatica are not eligible for participation. Participants with a history of sciatica who have been asymptomatic for ≥3 months and who have no evidence of radiculopathy or sciatic neuropathy on thorough neurologic examination are eligible for participation.
7. History of other disease that may involve the index knee, including inflammatory joint disease such as rheumatoid arthritis (RA), seronegative spondyloarthropathy (e.g., ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease-related arthropathy), crystalline disease (e.g., gout), endocrinopathies, metabolic joint diseases, lupus erythematosus, joint infections, Paget's disease, or tumours.
8. History of hypersensitivity to PPS, heparin or heparin-like drugs, or drugs of a similar chemical or pharmacological class.
9. Predisposition to hypersensitivity due to multiple (2 or more) atopic diseases (such as atopic eczema, asthma, and chronic allergic rhinitis and/or rhinoconjunctivitis) or multiple (2 or more) severe allergies.
10. Allergy or contraindication to tetracosactide (Synacthen®), cosyntropin (Cortrosyn®).
11. Allergy or contraindication to gadolinium.
12. Chronic medical conditions including but not limited to those stated below requiring medical regime changes within 60 days before Day 1.
Concurrent unstable peripheral, cardiac, and cerebral vascular disease, poorly controlled chronic obstructive pulmonary disease and asthma, coagulopathies, uncontrolled neurological conditions, active tuberculosis, active infections, symptomatic cardiac arrhythmias, adrenal insufficiency (primary or central), nephrotic syndrome, cirrhosis (Child-Pugh stage B or C), Gilbert syndrome, uncontrolled diabetes, and uncontrolled hypothyroidism or hyperthyroidism, or mental or emotional disorders that preclude reliable study participation.
13. History of pituitary irradiation or recent (within 1 year) history of transsphenoidal surgery.
14. Any cancer within the previous 5 years, except for basal cell carcinomas.
15. History or current autoimmune polyglandular syndromes.
16. Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per the protocol.
17. Current treatment with anticoagulants or antiplatelet drugs within 2 weeks before Day 1, excluding aspirin ≤150 mg/day.
18. Previous treatment with PPS in any form.
19. Current or recent (within 90 days before Day 1) immunosuppressive or immunomodulatory (with immunosuppressive effects) systemic therapy including but not limited to oral, inhaled, intranasal, intra-articular (IA) and topical corticosteroids (occasional use of topical, inhaled or intranasal corticosteroids is acceptable).
20. Use of NSAIDs with 2 weeks before Day 1.
21. Use of opioids within 6 weeks before Day 1.
22. Use of glucosamine or chondroitin within 6 weeks before Day 1.
23. Use of bisphosphonates and denosumab within 12 weeks before Day 1.
24. Use of iloprost within 12 weeks before Day 1.
25. Use of a knee brace on the index knee within 2 weeks before Day 1.
26. Systemic steroids administered intravenously, intramuscularly, or orally for OA or other indications within 8 weeks before Day 1.
27. Intra-articular (IA) injections to the index knee: steroids within 12 weeks before Day 1; hyaluronic acid (HA) or any other IA injections within 24 weeks before Day 1.
28. Stem cells or platelet-rich plasma within 12 months of Day 1.
29. Cannabinoids within 30 days before Day 1.
30. Use of individual vitamins and dietary supplements known to alter haemostasis within 2 weeks before Day 1, including ajoene, birch bark, cayenne, Chinese black tree fungus, cumin, evening primrose oil, feverfew, garlic, ginger, ginkgo biloba, ginseng, grapeseed extract, milk thistle, omega 3 fatty acids, onion extract, St. John's wort, turmeric, vitamins C and E, vitamin K, (multivitamins allowed).
31. Known exposure to heparin within the last 100 days as determined by history of drug use or history of the following medical conditions or interventions: cardiac bypass surgery or thromboembolic disease.
32. Treatment with dehydroepiandrosterone sulfates (DHEA-S) within 6 weeks before Day 1.
33. Chronic use of oral glucocorticoid receptor antagonists or cortisol synthesis inhibitors within 12 weeks before Day 1.
34. Biotin within 72 hours before Screening.
35. Megestrol acetate within 6 weeks before Day 1.
36. Participation in another clinical trial or administration of any IP or experimental product within 24 weeks or 5 half-lives (whichever is longer) before Day 1.
37. Activated partial thromboplastin time \[aPTT\]) \> 36 seconds, platelets \<150,000/μL, or liver enzyme tests (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) ≥ 2 × ULN at Screening.
38. Total bilirubin ≥1.5 ULN.
39. Active or chronic hepatitis B virus, hepatitis C virus, or uncontrolled HIV infection (detectable virus or diagnosis of AIDS); participants with HIV infection must be on chronic suppressive antiviral medication.
40. Evidence of any of the following conditions in any screening imaging: excessive malalignment (≥10 degrees varus or valgus) of the knee, subchondral insufficiency fracture (SIF), osteonecrosis/bone infarct, osteochondritis dissecans, stress or acute fracture, atrophic OA, pathologic fracture, primary or metastatic tumour, infectious arthritis or osteomyelitis, chronic or acute, Charcot's knee joint, synovial chondromatosis, certain posterior root tears of the meniscus, bone contusion, bone marrow oedema syndrome, bone marrow infiltration, gout, severe chondrocalcinosis, other arthropathies (e.g., RA, psoriatic arthritis), systemic metabolic bone disease (e.g., Paget's disease, metastatic calcifications) or other conditions identified by a radiologist or Medical Monitor which may interfere with a participant's assessment of pain.
41. Any clinically significant abnormalities on clinical chemistry, haematology, urinalysis, physical examination, medical history, or vital signs as judged by the Investigator (at Screening).
42. Resting, supine blood pressure (BP) ≥160 mmHg in systolic pressure or ≥100 mmHg in diastolic pressure at Screening. If a participant is found to have uncontrolled and/or untreated significant hypertension at Screening and antihypertensive treatment is initiated, assessment for study eligibility should be deferred until BP and antihypertensive medication have been stable for at least 1 month. For participants with previously diagnosed hypertension, antihypertensive medications must be stable for at least 1 month before Screening.
43. Any macular findings on clinical examination or imaging suggestive of: moderate or advanced dry macular degeneration, geographic atrophy, moderate or advanced myopic degeneration, wet macular degeneration, pattern dystrophy or other pigmentary maculopathy, moderate or severe diabetic or hypertensive retinopathy, recent retinal vascular occlusion, macular hole or advanced epiretinal membrane with associated macular oedema, retinal dystrophy, toxic retinal maculopathy, chronic central serous retinopathy, presence of significant subretinal or intraretinal fluid (OCT finding), presence of vitelliform or vitelliform-like macular changes (OCT and clinical finding), severe maculopathy not otherwise specified.
44. Morning cortisol \<3 μg/dL.
45. Adrenocorticotropic hormone (ACTH) \<10 pg/mL.
46. US/Canada only: Morning cortisol ≥3 μg/dL and \<10 μg/dL and peak cortisol (by ACTH stimulation \[250 μg, IM\] test) \<18 μg/dL at both 30 min and 60 min post stimulation.
47. Current hyperkalaemia and/or hyponatremia.
48. Contraindication to MRI.
49. Largely or wholly incapacitated (e.g., bedridden or confined to a wheelchair, permitting little or no self-care).
50. Major surgery or anticipated surgery during the study.
51. Currently hospitalised or any planned hospitalizations during the study.
52. Plan for total knee reconstruction in affected knee(s) during the study.
53. Knee surgery or trauma to the index knee within 1 year before Day 1.
54. A history of drug or alcohol abuse and/or dependence within the 12 months before Screening that, in the opinion of the Investigator, may affect participant ability to comply with study requirements.
55. An employee of the Sponsor, clinical research organisation(s), or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Paradigm Biopharmaceuticals Ltd.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Chief Medical Officer, Medical
Role: STUDY_DIRECTOR
Paradigm Biopharmaceuticals
Locations
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Onyx Clinical Research-Peoria
Peoria, Arizona, United States
Site Status
RECRUITING
Del Sol Research Management, LLC
Tucson, Arizona, United States
Site Status
RECRUITING
Orange County Research Institute
Anaheim, California, United States
Site Status
RECRUITING
Core Healthcare Group
Cerritos, California, United States
Site Status
RECRUITING
Arrow Clinical Trials
Daytona Beach, Florida, United States
Site Status
RECRUITING
AGA Clinical Trials
Hialeah, Florida, United States
Site Status
RECRUITING
Well Pharma Medical Research
Miami, Florida, United States
Site Status
RECRUITING
K2 Medical Research
Orlando, Florida, United States
Site Status
RECRUITING
Progressive Medical Research
Port Orange, Florida, United States
Site Status
RECRUITING
Phoenix Clinical Research
Tamarac, Florida, United States
Site Status
RECRUITING
Conquest Research
Winter Park, Florida, United States
Site Status
RECRUITING
Chicago Clinical Research, Inc
Chicago, Illinois, United States
Site Status
RECRUITING
Northwestern University
Chicago, Illinois, United States
Site Status
RECRUITING
Profound Research
Farmington Hills, Michigan, United States
Site Status
RECRUITING
Insight Research Institute
Flint, Michigan, United States
Site Status
RECRUITING
Rochester Medical Group
Rochester Hills, Michigan, United States
Site Status
RECRUITING
Onyx Clinical Research - Rochester Hills
Troy, Michigan, United States
Site Status
RECRUITING
Physician Research Collaboration
Lincoln, Nebraska, United States
Site Status
RECRUITING
Drug Trials America
Hartsdale, New York, United States
Site Status
RECRUITING
IMC Clinical Research Manhattan
New York, New York, United States
Site Status
RECRUITING
FutureSearch Trials of Neurology
Austin, Texas, United States
Site Status
RECRUITING
FutureSearch Trials of Dallas
Dallas, Texas, United States
Site Status
RECRUITING
Vilo Research Group
Houston, Texas, United States
Site Status
RECRUITING
DM Clinical Research
Houston, Texas, United States
Site Status
RECRUITING
Clinical Trial Network
Houston, Texas, United States
Site Status
RECRUITING
Epic Clinical Research
Lewisville, Texas, United States
Site Status
RECRUITING
Quality Research Inc.
San Antonio, Texas, United States
Site Status
RECRUITING
Canopy Clinical Research-Northern Beaches
Brookvale, New South Wales, Australia
Site Status
RECRUITING
Novatrials
Charlestown, New South Wales, Australia
Site Status
RECRUITING
Canopy Clinical Research-Wollongong
Wollongong, New South Wales, Australia
Site Status
RECRUITING
Mater Health Brisbane
South Brisbane, Queensland, Australia
Site Status
RECRUITING
Griffith University
Southport, Queensland, Australia
Site Status
RECRUITING
Sportsmed
Stepney, South Australia, Australia
Site Status
RECRUITING
Sportsmed Biologic LTD
Box Hill, Victoria, Australia
Site Status
RECRUITING
Countries
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United States
Australia
Central Contacts
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Facility Contacts
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Other Identifiers
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PARA_OA_012
Identifier Type: -
Identifier Source: org_study_id
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ENROLLING_BY_INVITATION
PHASE3
Pivotal Study to Evaluate Efficacy and Safety of SP5M002 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis
NCT06399042
ACTIVE_NOT_RECRUITING
PHASE3
A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain
NCT03429049
COMPLETED
PHASE3
Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
NCT02558439
COMPLETED
PHASE2
Study of OLP-1002 Injections for Reducing Moderate to Severe Pain Due to Osteoarthritis in Hip and/or Knee Joint
NCT05216341
COMPLETED
PHASE2
Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis
NCT03203408
COMPLETED
NA
A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis
NCT07225829
RECRUITING
PHASE2
Investigating the Effect of Deep Sea Krill Oil Supplementation in Osteoarthritis of the Knee
NCT03483090
COMPLETED
PHASE2
A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee
NCT02024529
COMPLETED
PHASE3
Intra-articular Platelet-Rich Plasma Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis
NCT03491761
RECRUITING
PHASE2
A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee
NCT06884865
RECRUITING
PHASE2
A Phase 1/2a Study to Evaluate Single Intraarticular Injections of 3 Dose Levels of SYN321 and Placebo in Patients With Symptomatic Knee Osteoarthritis
NCT06989645
RECRUITING
PHASE1/PHASE2
Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)
NCT06191848
RECRUITING
PHASE4
Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee
NCT01688934
COMPLETED
PHASE2
A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain
NCT02192190
TERMINATED
PHASE2
A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee
NCT03231280
COMPLETED
PHASE1/PHASE2
Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee
NCT00653432
COMPLETED
NA
Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
NCT03727022
COMPLETED
PHASE2
Comparison of Effectiveness Between PL and PRP on Knee Osteoarthritis: a Prospective,Randomized,Placebo-controlled Trial
NCT03734900
UNKNOWN
PHASE4
Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA
NCT02110238
COMPLETED
NA
Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee
NCT00988091
COMPLETED
PHASE3