We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Investigate The Duration of Treatment Effect and Re-treatment With Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult 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 benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04814719
Recruitment Status : Not yet recruiting
First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Paradigm Biopharmaceuticals Ltd. ( Paradigm Biopharmaceuticals USA (INC) )

Brief Summary:

The purpose of this study is to measure the duration of treatment effect and response to re-treatment with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adult participants with knee osteoarthritis (OA) pain.

Study details include:

  • The study duration will be up to 28, 56, 68, or 80 weeks depending on treatment received in the parent study and response to treatment.
  • If participating in the Treatment Part of the study:

    • The treatment duration will be up to 6 weeks
    • The visit frequency will be twice weekly during the Treatment Period.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Pentosan Polysulphate Sodium Drug: Placebo (Sodium Chloride Injection, 0.9%) Phase 3

Detailed Description:

This is a follow-up extension study to determine duration of treatment effect and assess long-term safety and response to re-treatment with PPS in participants with knee OA pain who completed the parent study study (PARA_OA_002).

Study PARA_OA_006 consists of Follow-up Part 1 and Part 2 and a Treatment Part

Eligible participants will be enrolled in Study PARA_OA_006 at the completion of the parent study and will enter the 6-month Follow-up Part 1. At the end of Follow-up Part 1, participants will begin the Treatment Part of the study, continue to Follow-up Part 2, or end the study depending on the treatment received in the parent study, their response to treatment during the parent study, and/or their response status at the end of the Follow-up Part 1

Participants in the Treatment Part will be administered twice weekly subcutaneous (SC) injections for 6 weeks:

  • The PPS dose regimen will be 1 of the 3 dose regimens evaluated in Stage 1 of the parent study and selected by the independent data monitoring committee (DMC).
  • Placebo will be 0.9% w/v sodium chloride injection.

The maximum duration of study participation will be approximately:

  • 28 weeks for participants who complete Follow-up Part 1 and are not eligible to continue to Follow-up Part 2 or the Treatment Part
  • 56 weeks for participants who complete Follow-up Part 1 and the Treatment Part
  • 68 weeks for participants who complete Follow-up Part 1, Follow-up Part 2 up to Week 40, and the Treatment Part
  • 80 weeks for participants who complete Follow-up Parts 1 and 2 or Follow-up Part 1, Follow-up Part 2 up to Week 52 and the Treatment Part

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 938 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Extension Study to Evaluate Duration of Treatment Effect and Re-treatment of Pentosan Polysulfate Sodium in Participants With Knee Osteoarthritis Pain
Estimated Study Start Date : December 24, 2021
Estimated Primary Completion Date : October 24, 2024
Estimated Study Completion Date : October 24, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Pentosan Polysulfate Sodium
Pentosan Polysulfate Sodium (PPS) at Dose and frequency selected in Stage 1 of Parent Study for 6 weeks
Drug: Pentosan Polysulphate Sodium
Subcutaneous Injection (100mg/ml)

Placebo Comparator: Placebo
Placebo for 6 weeks
Drug: Placebo (Sodium Chloride Injection, 0.9%)
Placebo to match PPS




Primary Outcome Measures :
  1. Time from initial response in the parent study (PARA_OA_002) to loss of OMERACT-OARSI response through Follow-up Week 28 (Part 1) [ Time Frame: From initial response time in parent study upto Week 28 ]
    Time taken to loose response from participants considered OMERACT- OARSI responders in the parent study. 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).

  2. Time from initial response in the parent study (PARA_OA_002) to loss of OMERACT-OARSI response through Follow-up Week 80 (Part 2) [ Time Frame: From initial response time in parent study upto Week 80 ]
    Time taken to loose response from participants considered OMERACT- OARSI responders in the parent study.


Secondary Outcome Measures :
  1. Percentage of participants meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International - Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Week 12, 28, 40, 52 and 80 [ Time Frame: Week 12, 28, 40, 52 and 80 ]
    Percentage of participants considered OMERACT- OARSI responders at each timepoint..

  2. Percentage of participants meeting OMERACT-OARSI Responder Index at Treatment Days 11, 25, 39, 56, 84, 112, 140 and 168 [ Time Frame: Baseline, Days 11, 25, 39, 84, 112, 140 and 168 ]
    Percentage of participants considered OMERACT- OARSI responders at each timepoint following treatment/re-treatment

  3. Change from baseline of the parent study in knee pain as assessed by the average pain sub-scale score of the Western Ontario and McMaster Universities (WOMAC®) numeric rating scale (NRS) 3.1 Index at Weeks 12, 28, 40, 52, and 80 [ Time Frame: Baseline (Parent Study), Weeks 12, 28, 40, 52 and 80 ]
    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.

  4. Change from baseline of the parent study in function as assessed by the average function sub-scale score of the Western Ontario and McMaster Universities (WOMAC®) numeric rating scale (NRS) 3.1 Index at Weeks 12, 28, 40, 52, and 80 [ Time Frame: Baseline (Parent Study), Weeks 12, 28, 40, 52 and 80 ]
    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.

  5. Change from baseline of the parent study in knee pain of >=25% and >=50% as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Weeks 12, 28, 40, 52, and 80 [ Time Frame: Baseline (Parent Study), Weeks 12, 28, 40, 52 and 80 ]
    Percentage of participants with reduction in WOMAC pain intensity of at least >=25% or >=50% compared to baseline in the parent study as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Weeks 12, 28, 40, 52 and 80

  6. Change from baseline of the parent study in function of >=25% and >=50% as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index at Weeks 12, 28, 40, 52, and 80 [ Time Frame: Baseline (Parent Study), Weeks 12, 28, 40, 52 and 80 ]
    Percentage of participants with improvement in WOMAC function of at least >=25% or >=50% compared to baseline in the parent study

  7. Change from baseline of the parent study in stiffness as assessed by the average stiffness sub-scale score of the Western Ontario and McMaster Universities (WOMAC®) numeric rating scale (NRS) 3.1 Index at Weeks 12, 28, 40, 52, and 80 [ Time Frame: Baseline (Parent Study), Weeks 12, 28, 40, 52 and 80 ]
    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

  8. Change from baseline of the parent study as assessed by the average overall score of the Western Ontario and McMaster Universities (WOMAC®) numeric rating scale (NRS) 3.1 Index at Weeks 12, 28, 40, 52, and 80 [ Time Frame: Baseline (Parent Study), Weeks 12, 28, 40, 52 and 80 ]
    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

  9. Patient Global Impression of Change (PGIC) at Weeks 12, 28, 40, 52 and 80 [ Time Frame: Weeks 12, 28, 40, 52 and 80 ]
    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".

  10. Change from baseline of the parent study at Weeks 12, 28, 40, 52 and 80 in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36) [ Time Frame: Weeks 12, 28, 40, 52 and 80 ]
    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.

  11. Change from baseline of the parent study at Weeks 12, 28, 40, 52 and 80 in Work Productivity and Activity Impairment (WPAI) questionnaire. [ Time Frame: Weeks 12, 28, 40, 52 and 80 ]
    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

  12. Change from baseline at Treatment 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, 56, 84 112, 140 and 168 ]
    Change from baseline following treatment/re-treatment. 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.

  13. Change from baseline at Treatment Days 11, 25, 39, 84, 112, 140 and 168 in function as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index. [ Time Frame: Baseline, Days 11, 25, 39, 56, 84 112, 140 and 168 ]
    Change from baseline of function following treatment/re-treatment. WOMAC: Physical function refers to participant's ability to move around and perform usual activities of daily living.

  14. Change from baseline at Treatment Days 11, 25, 39, 84, 112, 140 and 168 in stiffness as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index. [ Time Frame: Baseline, Days 11, 25, 39, 56, 84 112, 140 and 168 ]
    Change from baseline of stiffness following treatment/re-treatment. 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

  15. Change from baseline at Treatment Days 11, 25, 39, 84, 112, 140 and 168 as assessed by the average overall score of the WOMAC® NRS 3.1 Index. [ Time Frame: Baseline, Days 11, 25, 39, 56, 84 112, 140 and 168 ]
    Change from baseline of WOMAC overall score following treatment/re-treatment. 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

  16. Patient Global Impression of change at Day 39, 84, 112, 140 and 168 [ Time Frame: Days 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".

  17. Change from baseline at Treatment 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.

  18. Change from baseline at Treatment Days 56, 84, 112, 140, and 168 in Work Productivity and Activity Impairment (WPAI) questionnaire score [ Time Frame: Days 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..

  19. 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 Treatment Days 11, 25, 39, 84, 112, 140 and 168 [ Time Frame: Baseline, Days 11, 25, 39, 46, 84 112, 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

  20. Change from baseline in function of >=25% and >=50% as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index at Treatment Days 11, 25, 39, 84, 112, 140 and 168 [ Time Frame: Baseline, Days 11, 25, 39, 46, 84 112, 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 pain sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 56, 84 112, 140 and 168

  21. Number of days of rescue medication used from through followup to end of study [ Time Frame: Baseline up to Week 80 ]
    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. Number of participants with any use of rescue medication will be summarized

  22. Number of days of rescue medication used from Treatment Day 1 through Day 168 [ Time Frame: Day 1 through 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 Treatment Day 1 and Day 168. Number of participants with any use of rescue medication will be summarized

  23. Incidence of Serious Adverse Events (SAE), Adverse Events (AE) related to the Investigational Product (IP), and AEs related to any intervention for knee pain through followup to end of study [ Time Frame: Baseline up to Week 80 ]
    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.

  24. Incidence of Treatment Emergent Adverse Events (TEAE) through Treatment to Day 168 [ Time Frame: Baseline up to Day 168 ]
    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.

  25. Incidence of Treatment-emergent clinical laboratory abnormalities from treatment to end of study [ Time Frame: Baseline up to Day 168 ]
    Treatment-emergent clinical laboratory abnormalities are deemed clinically significant 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.


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] ]
    Following treatment/re-treatment 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. Change in subchondral Bone Marrow Lesion (BML) area and volume on Magnetic Resonance Imaging (MRI) from baseline of the parent study at Week 28 and 80 [ Time Frame: Baseline (parent study), Week 28 and 80 ]
    MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate

  3. Change in joint synovitis/effusion volume on MRI from baseline of the parent study at Week 28 and 80 [ Time Frame: Baseline (parent study), Week 28 and 80 ]
    MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate

  4. Change in cartilage volume on MRI from baseline of the parent study at Week 28 and 80 [ Time Frame: Baseline (parent study), Week 28 and 80 ]
    MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate

  5. Change in bone shape on MRI from baseline of the parent study at Week 28 and 80 [ Time Frame: Baseline (parent study), Week 28 and 80 ]
    MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate

  6. Change in joint space width on X-ray from baseline of the parent study at Week 28 and 80 [ Time Frame: Baseline (parent study), Week 28 and 80 ]
    X-Rays will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate

  7. Change in joint space width on MRI from baseline of the parent study at Week 28 and 80 [ Time Frame: Baseline (parent study), Week 28 and 80 ]
    MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who completed Day 168 of Study PARA_OA_002 (ie, did not discontinue/withdrew prematurely from the parent study).
  • 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.
  • Agrees to continue use of paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy, if required.

Exclusion Criteria:

  • Major surgery or anticipated surgery during the study.
  • Currently hospitalised or any planned hospitalisations during the study.
  • Plan for total knee reconstruction in affected knee(s) during the study.
  • 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.

Treatment Inclusion Criteria:

  • Body mass index of >=18 to <=39.0 kg/m2
  • Willing to abstain from use of oral and topical NSAIDs, opioids, and all other systemic pain medications (except acetaminophen/paracetamol per rescue protocol) from 2 weeks before Treatment Day 1 to end of study.
  • Agrees to continue to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy if required

Treatment Exclusion Criteria

  • Major surgery or anticipated surgery during the study.
  • Currently hospitalised or any planned hospitalisations during the study.
  • Plan for total knee reconstruction in affected knee(s) during the study.
  • 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.
  • 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 (HIT) including history of or laboratory confirmed HIT (positive or equivocal antibodies against platelet factor 4 (anti-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 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 Treatment 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.
  • 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.
  • Values of aPTT at Screening that are below the lower limit of normal should be discussed with the Medical Monitor.
  • 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.
  • Any clinically significant abnormalities on clinical chemistry, haematology, urinalysis, physical examination, medical history, 12-lead electrocardiogram (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 anti-hypertensive medication have been stable for at least 1 month. For participants with previously diagnosed hypertension, anti-hypertensive 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 within 12 weeks before treatment Day1or anticipated surgery.
  • Currently hospitalised or any planned hospitalisations during the treatment part.
  • Plan for total knee reconstruction in affected knee(s) during the treatment part.
  • Knee surgery or trauma to the index knee within 1 year before treatment 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.

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): NCT04814719


Contacts
Layout table for location contacts
Contact: Clinical Operations Director +61 492 922 860 info@paradigmbiopharma.com

Locations
Layout table for location information
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Contact: Narina Simonian    312-503-5780    n-simonian@northwestern.edu   
Australia, Victoria
Emeritus Research
Camberwell, Victoria, Australia, 3124
Contact: Teresa Ringeri    +61395096166    teresaringeri@emeritusresearch.com   
Sponsors and Collaborators
Paradigm Biopharmaceuticals USA (INC)
Investigators
Layout table for investigator information
Principal Investigator: Thomas Schnitzer Northwestern University Feinberg School of Medicine
Layout table for additonal information
Responsible Party: Paradigm Biopharmaceuticals USA (INC)
ClinicalTrials.gov Identifier: NCT04814719    
Other Study ID Numbers: PARA_OA_006
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pentosan Sulfuric Polyester
Anticoagulants