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Trial record5 of 10for: Pentosan

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Treatment Effects of Subcutaneous Injections ofPentosanPolysulfate Sodium Versus Placebo in Participants With Knee Osteoarthritis Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.Know the risks and potential benefitsof clinical studies and talk to your health care provider before participating. Read ourdisclaimerfor details.

	ClinicalTrials.gov Identifier: NCT04809376
1	Recruitment Status: Not yet recruiting First Posted: March 22, 2021 Last Update Posted: March 22, 2021 SeeContacts and Locations

Sponsor:

Paradigm Biopharmaceuticals USA (INC)

Information provided by (Responsible Party):

Paradigm Biopharmaceuticals Ltd. ( Paradigm Biopharmaceuticals USA (INC) )

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Study Description

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Brief Summary:

The purpose of this study is to measure the change in pain and function with subcutaneous injections ofpentosanpolysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee osteoarthritis pain.

Study details include:

• The study duration will be up to 28 weeks per participant
• The treatment duration will be 6 weeks.
• The visit frequency will be twice weekly during treatment..

	Condition or disease	Intervention/treatment	Phase
1	Osteoarthritis, Knee	Drug:PentosanPolysulfate SodiumDrug: Placebo (Sodium Chloride Injection, 0.9%)Drug:PentosanPolysulfate Sodium Fixed Dose	Phase 2Phase 3

Detailed Description:

This is a 2-stage, adaptive, randomized, double-blind, placebo-controlled, multicenter study that will evaluate the dose and treatment effect of PPS in participants with knee OA pain.

In Stage 1 (dose selection), approximately 468 participants will be randomised 1:1:1:1 to receive 1 of 3 PPS dose regimens or placebo for 6 weeks. A minimum of 96 participants (24 within each dose group) will be assigned to the Pharmacokinetic (PK) subset.

Participants in Stage 1 will be randomly allocated to receive:

• 2 mg/kg calculated for ideal body weight (IBW) PPS twice weekly
• 2 mg/kg IBW PPS once weekly + placebo once weekly
• 100/150 mg PPS ≤65/>65 kg IBW once weekly + placebo once weekly
• placebo twice weekly

In Stage 2, approximately 470 participants will be randomized 1:1 to receive the selected PPS dose regimen or placebo for 6 weeks. Approximately 150 participants (75 per group) will be assigned to the PK subset.

Participants in Stage 2 will be randomly allocated to receive:

• One of the 3 Stage 1 PPS dose regimens selected by the DMC
• placebo twice weekly

The maximum duration for each participant is approximately 28 weeks, which includes:

• 4-week Screening Period from Day -28 to Day -1
• 6-week Treatment Period from Day 1 to Day 39
• 18-week Follow-up Period from Day 40 to Day 168

Study Design

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	Study Type:	Interventional (Clinical Trial)
1	EstimatedEnrollment:	938 participants
2	Allocation:	Randomized
3	Intervention Model:	Parallel Assignment
4	Masking:	Triple (Participant, Investigator, Outcomes Assessor)
5	Primary Purpose:	Treatment
6	Official Title:	A 2-stage, Adaptive, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate Dose and Treatment Effect ofPentosanPolysulfate Sodium Compared With Placebo in Participants With Knee Osteoarthritis Pain
7	EstimatedStudy Start Date:	June 26, 2021
8	EstimatedPrimary Completion Date:	August 17, 2022
9	EstimatedStudy Completion Date:	January 6, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Geneticsrelated topics:Osteoarthritis

MedlinePlusrelated topics:Osteoarthritis

Drug Informationavailable for:Pentosan polysulfatePentosan polysulfate sodium

U.S. FDA Resources

Arms and Interventions

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	Arm	Intervention/treatment
1	Experimental: PPS Twice Weekly PentosanPolysulfate Sodium (PPS) twice weekly for 6 weeks	Drug:PentosanPolysulfate Sodium Subcutaneous Injection, 2mg/kg Ideal body Weight (IBW)
2	Experimental: PPS Once Weekly PentosanPolysulfate Sodium (PPS) + placebo once weekly for 6 weeks	Drug:PentosanPolysulfate Sodium Subcutaneous Injection, 2mg/kg Ideal body Weight (IBW) Drug: Placebo (Sodium Chloride Injection, 0.9%) Placebo to match PPS
3	Experimental: PPS Fixed Dose Once Weekly PentosanPolysulfate Sodium (PPS) Fixed dose (100mg or 150mg) once weekly + placebo once weekly for 6 weeks	Drug: Placebo (Sodium Chloride Injection, 0.9%) Placebo to match PPS Drug:PentosanPolysulfate Sodium Fixed Dose Subcutaneous Injection, 100/150 mg if ≤65/>65 kg IBW
4	Placebo Comparator: Placebo Placebo twice weekly for 6 weeks	Drug: Placebo (Sodium Chloride Injection, 0.9%) Placebo to match PPS

Outcome Measures

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Primary Outcome Measures:

1. Change from baseline at Day 56 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index. [ Time Frame: Baseline, Day 56 ]
   WOMAC: The WOMAC® NRS 3.1 Index is a validated, self-administered, health status questionnaire that assesses pain, stiffness, and function in patients with hip or knee OA . The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours. It is calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain sub-scale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.

Secondary Outcome Measures:

1. Change from baseline at Days 11, 25, 39. 56, 84, 112, 140 and 168 in function as assessed by the average functional sub-scale score of the WOMAC® Index. [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140 and 168 ]
   WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function sub-scale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee) during the past 48 hours.
2. Change from baseline at Days 11, 25, 39, 84, 112, 140 and 168 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index. [ Time Frame: Baseline, Days 11, 25, 39, 84, 112, 140 and 168 ]
   WOMAC: The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours.
3. Percentage of patients meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International - Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Days 39, 56, 84, 112, 140, and 168 [ Time Frame: Baseline, Days 39, 56, 84, 112, 140 and 168 ]
   Participants are considered as an OMERACT-OARSI responder: if the change (improvement) from baseline to day of interest was greater than or equal to >= 50 percent and >= 2 units in either WOMAC pain sub-scale or physical function sub-scale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain sub-scale score, 2) WOMAC physical function sub-scale score, 3) Patient Global Impression of Change (PGIC).
4. Change from baseline in knee pain of >=25% and >=50% as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 56, 84, 112, 140, and 168 [ Time Frame: Baseline, Days 11, 25, 39, 112, 140 and 168 ]
   Percentage of participants with reduction in WOMAC pain intensity of at least >=25% or >=50% compared to baseline as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 56, 84, 112, 140, and 168.
5. Change from baseline in function of >=25% and >=50% as assessed by the average functional sub-scale score of the WOMAC® NRS 3.1 Index from baseline at Days 11, 25, 39, 112, 140, and 168 [ Time Frame: Baseline, Days 11, 25, 39, 112, 140, and 168 ]
   Percentage of participants with improvement in WOMAC function of at least >=25% or >=50% compared to baseline as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 56, 84, 112, 140, and 168.
6. Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 in knee stiffness as assessed by the average stiffness sub-scale score of the WOMAC® NRS 3.1 Index [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168 ]
   WOMAC: The WOMAC stiffness sub-scale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee) during the past 48 hours.
7. Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 overall as assessed by the overall score of WOMAC® NRS 3.1 Index [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168 ]
   WOMAC: The WOMAC® NRS 3.1 Index consists of 24 questions and produces 3 sub-scales scores for pain (5 questions), stiffness (2 questions), and function (17 questions) and a total score that summarizes overall disability.
8. PGIC scores at Days 39, 56, 84 112, 140, and 168 [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168 ]
   The PGIC is a self-administered question that rates participants overall improvement in chronic pain since beginning treatment from 1 "no change (or condition has worsened)" to 7 "a great deal better" in response to the question "Since beginning treatment, how would you describe the change (if any) in activity, limitation, symptoms, emotions, and overall QoL related to your arthritis".
9. Change from baseline at Days 11, 25, 39, 56, 84, 112, 140, and 168 in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36) [ Time Frame: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168 ]
   The SF-36 v2 is a 36-item, patient-reported survey of patient health, consisting of 8 scaled scores, which are the weighted sums of the questions in their section. The 1-week recall form asks the respondent to answer the questions as they pertain to the way he or she felt or acted during the past week.
10. Change from baseline at Days 56, 84, 112, 140, and 168 in Work Productivity and Activity Impairment (WPAI) questionnaire score [ Time Frame: Baseline, Day 56, 84, 112, 140 and 168 ]
    This WPAI questionnaire (WPAI:OA-knee) is a validated self-administered questionnaire that assesses work impairment due to OA . The questionnaire gathers information on employment status, hours worked, hours missed due to OA, and hours missed for any other reasons.
11. Number of days of rescue medication used from Day 1 to Day 168 [ Time Frame: Baseline up to Day 168 ]
    In case of inadequate pain relief, either acetaminophen/paracetamol up to 3000 mg per day or topical analgesics, up to 4 days in a week could be taken as rescue medication between day 1 and Day 168. Number of participants with any use of rescue medication during the particular study week will be summarized
12. Incidence of treatment-emergent Adverse Event (TEAEs), including serious AEs (SAEs) upto end of study [ Time Frame: Baseline up to Day 168 ]

    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

    An SAE is any untoward medical occurrence that at any dose results in one or more of the following outcomes: death; life-threatening; requires in-patient hospitalization or prolongation of an existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; is an important medical event. Treatment-emergent are events between the first dose of study drug and up to Day 168 that were absent before treatment or that worsened relative to pre-treatment state.

13. Incidence of Treatment-emergent clinical laboratory abnormalities upto end of study [ Time Frame: Baseline up to Day 168 ]
    Treatment-emergent clinical laboratory abnormalities are abnormalities in labs between the first dose of study drug and up to Day 168 that were absent before treatment or that worsened relative to pre-treatment state
14. Incidence of clinically significant changes in electrocardiograms (ECG) compared with baseline at Day 15 and 39 [ Time Frame: Baseline, Day 1, Day 15 and Day 39 ]
    Clinically significant changes in ECGs between the first administration of study drug and up to Day 39 that were absent before treatment or that worsened relative to pre-treatment state.

Other Outcome Measures:

1. Number of participants with an Anti-Drug-Antibody (ADA) response at Days 11, 25, 39, 56 and 84 [ Time Frame: Baseline, Days 11, 25, 39, 56 and 84 ]
   Human serum ADA samples will be analyzed for the presence or absence of anti-drug-antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).
2. Stage 1: Change in PPS plasma concentration over time of single and multiple doses at Days 1, 15 and 39 [ Time Frame: 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 ]
   Blood samples for assay of plasma PPS concentration will be obtained from a subset of patients before dosing and 2, 4, and 6 hours after dosing on study Days 1,15 and 39, and assayed using a sensitive, validated [binding, etc.] bioanalytical method. Plasma concentrations of PPS will be tabulated by time and participant and inspected for relationship to dose during titration and stable treatment phases.
3. Stage 2: Change in PPS plasma concentration over time of single and multiple doses at Days 1, 15 and 39 [ Time Frame: Stage 2: Day 1, 15 and 39 - pre-dose and 2 and 4 hours. Pre-dose on Days 4, 8, 11, 18, 22, 25, 29, 32 and 36 ]
   Blood samples for assay of plasma PPS concentration will be obtained from a subset of patients before dosing and 2, 4, and 6 hours after dosing on study Days 1 15 and 39, and assayed using a sensitive, validated [binding, etc.] bioanalytical method. Plasma concentrations of PPS will be tabulated by time and participant and inspected for relationship to dose during titration and stable treatment phases.

Eligibility Criteria

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information,Learn About Clinical Studies.

	Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
1	Sexes Eligible for Study:	All
2	Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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.
• 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.

• Osteoarthritis pain in the index knee unresponsive (ie, the participant still experiences pain) to conservative therapy for >=6 months preceding Screening, defined as history indicating that:

  1. Acetaminophen/paracetamol therapy has not provided sufficient pain relief or participant is unable to take acetaminophen/paracetamol chronically/long term because of contraindication or inability to tolerate; AND
  2. At least 1 oral non-steroidal anti-inflammatory drug (NSAID, including cyclooxygenase-2 inhibitors) and/or topical NSAID therapy that has not provided sufficient pain relief or participant is unable to take NSAIDs because of contraindication or inability to tolerate.
• Average WOMAC NRS 3.1 Index pain sub-scale score of 4 to 10 in the index knee at Screening AND Day 1 AND a minimum pain score of 4 on either of the individual WOMAC NRS 3.1 Index questions of pain on walking on a flat surface or pain on climbing stairs at Screening AND Day 1.
• Average WOMAC NRS 3.1 Index function sub-scale score of 4 to 10 in the index knee at Screening and Day 1.
• Body mass index of >=18 to <=39.0 kg/m2
• 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.
• Current non-pharmacologic treatment regimen for knee OA 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.
• Willing to stop treatment with oral and topical NSAIDs, opioids, and all other systemic pain medications (except acetaminophen/paracetamol per rescue protocol) from 2 weeks before Day 1 to end of study.
• Agrees to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy if required.
• Female subjects of childbearing potential and Male subjects must agree to comply with protocol specified contraceptive requirements

Exclusion Criteria:

• Documented or reported history of increased bleeding in the absence of anticoagulant or antiplatelet drugs or prior history of major bleeding episode in the presence of anticoagulant or antiplatelet therapy.
• History of idiopathic or immune-mediated thrombocytopenia including history of or laboratory confirmed HIT (positive or equivocal antibodies against platelet factor 4 [ie, PF4]).
• Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
• Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy, or other moderate to severe pain 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.
• History of other disease that may involve the index joint, including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease-related arthropathy), crystalline disease (eg, gout), endocrinopathies, metabolic joint diseases, lupus erythematosus, joint infections, Paget's disease, or tumours.
• History of osteonecrosis or osteoporotic fracture (ie, a participant with a history of osteoporosis and a minimally traumatic or atraumatic fracture).
• History of hypersensitivity to PPS, heparin or heparin-like drugs, or drugs of a similar chemical or pharmacological class.
• Current clinically significant medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's opinion, makes the participant unsuitable for the study. Chronic medical conditions will be allowed at the discretion of the Investigator but must be stable without necessitating medication changes within 30 days before Day 1.
• 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 protocol.
• Current treatment with anticoagulants or antiplatelet drugs, excluding aspirin <=100 mg/day.
• Previous treatment with PPS in any form.

• Current or recent (within 90 days before Day 1) immunosuppressive or immunomodulatory systemic therapy as follows:

  1. Chronic use of corticosteroids: >=15 mg/day of oral prednisolone or equivalent daily,
  2. Intermittent corticosteroids: >=40 mg/day of oral prednisolone or equivalent for 1 or more short courses of >3 days.
• Use of bisphosphonates within 12 weeks before Day 1.
• Use of denosumab and iloprost within 12 weeks before Day 1.
• Use of a knee brace on the index knee within 2 weeks before Day 1.
• Systemic steroids administered intravenously, intramuscularly, and orally for OA or other indications within 2 weeks before Day 1.
• Intra-articular injections to the index knee: steroids within 12 weeks; hyaluronic acid or any other intra-articular injections within 24 weeks before Day 1.
• Use of 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.
• 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.
• Activated partial thromboplastin time [aPTT]) > upper limit of normal (ULN), platelets <150,000/µL, or liver enzyme tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) >=2 × ULN at Screening.
• 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.
• Radiographic evidence of any of the following conditions in any Screening radiograph: excessive malalignment of the knee, severe chondrocalcinosis; other arthropathies (eg, rheumatoid arthritis, psoriatic arthritis, gout), systemic metabolic bone disease (eg, Paget's disease, metastatic calcifications), primary or metastatic tumour lesions, stress, or traumatic fracture.

• Radiographic evidence of any of the following conditions at Screening:

  1. subchondral insufficiency fractures
  2. spontaneous osteonecrosis of the knee
  3. osteonecrosis
  4. pathologic fracture
• Any clinically significant abnormalities on clinical chemistry, haematology, urinalysis, physical examination, medical history, 12-lead ECG, or vital signs as judged by the Investigator (at Screening).
• 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 anti-hypertensive 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.
• Largely or wholly incapacitated (eg, bedridden or confined to a wheelchair, permitting little or no self-care).
• Major surgery or anticipated surgery during the study.
• Currently hospitalized or any planned hospitalizations during the study.
• Plan for total knee reconstruction in affected knee(s) during the study.
• Knee surgery or trauma to the index knee within 1 year before Day 1.
• 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.
• Contraindication to MRI scans.
• An employee of the Sponsor, clinical research organisations 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.

Contacts and Locations

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number):NCT04809376

Contacts

	Contact: Clinical Operations Director	+61 492 922 860	[email protected]

Locations

United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Contact: Narina Simonian 312-503-5780 [email protected]
Australia, Victoria
Emeritus Research
Camberwell, Victoria, Australia, 3124
Contact: Teresa Ringeri +61395096166 [email protected]

Sponsors and Collaborators

Paradigm Biopharmaceuticals USA (INC)

Investigators

Principal Investigator:

Thomas Schnitzer

Northwestern University Feinberg School of Medicine

More Information

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Responsible Party:	Paradigm Biopharmaceuticals USA (INC)
ClinicalTrials.gov Identifier:	NCT04809376History of Changes
Other Study ID Numbers:	PARA_OA_002
First Posted:	March 22, 2021 Key Record Dates
Last Update Posted:	March 22, 2021
Last Verified:	March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Paradigm Biopharmaceuticals Ltd. ( Paradigm Biopharmaceuticals USA (INC) ):

Osteoarthritis Knee

Additional relevant MeSH terms:

Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases

Musculoskeletal Diseases Rheumatic Diseases PentosanSulfuric Polyester Anticoagulants

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