AzTrials
AzTrials

Osteoarthritis, KneePhase 2/3NCT04809376

Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain

A Phase 2/3 study testing Pentosan Polysulfate Sodium twice weekly, Pentosan Polysulfate Sodium Fixed Dose and Pentosan Polysulfate Sodium once weekly in people with Osteoarthritis, Knee, run by Paradigm Biopharmaceuticals USA (INC) at 33 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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 osteoarthritis pain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Pentosan Polysulfate Sodium twice weekly, Pentosan Polysulfate Sodium Fixed Dose and Pentosan Polysulfate Sodium once weekly
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
602 participants
Where
33 sitesin 2 countries
Study dates
19 Oct 2021to 6 Jan 2025
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be >= 18 years of age inclusive, at the time of signing the informed consent.
  • Clinical diagnosis of OA in the index knee by American College of Rheumatology criteria 1986 criteria.
  • 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:
  • 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
  • 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.
Show all 14Show fewer
  • Average WOMAC NRS 3.1 Index pain sub-scale score of 4 to 10 in the index knee at Screening 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.
  • Average WOMAC NRS 3.1 Index function sub-scale score of 4 to 10 in the index knee at Screening.
  • Body mass index of >=18 to <=39.0 kg/m2
  • Female subjects of childbearing potential and Male subjects must agree to comply with protocol specified contraceptive requirements
  • 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 (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.
  • Willing to stop treatment with oral and topical NSAIDs, 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.

Who cannot join

  • 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] and positive Serotonin Release Assay (SRA)].
  • Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
  • History of other bleeding disorders including haemophilia
  • •. Recent cerebral bleeding or operation on brain, spine, or eyes within 6 months of Day 1.
  • Spinal anaesthesia within 14 days of Day 1,
Show all 57Show fewer
  • 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.
  • 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
  • Allergy or contraindication to Tetracosactide
  • 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), uncontrolled diabetes and uncontrolled hypothyroidism or hyperthyroidism, or mental or emotional disorders that preclude reliable study participation.
  • History of pituitary irradiation or recent (within 1 year) history of transsphenoidal surgery
  • Any cancer within the previous 5 years, except for basal cell carcinomas.
  • Current hyperkalemia and/or hyponatremia.
  • History or current autoimmune polyglandular syndromes
  • 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 (with immunosuppressive effects) systemic therapy including but not limited to oral, inhaled, intranasal, intra-articular and topical corticosteroids (occasional use of topical, inhaled or intranasal corticosteroids is acceptable).
  • Use of opioids within 6 weeks before Day 1.
  • 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 8 weeks before Day 1.
  • Intra-articular injections to the index knee: steroids within 24 weeks; hyaluronic acid or any other intra-articular injections within 24 weeks before Day 1.
  • Cannabinoids within 30 days 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.
  • 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
  • Treatment with dehydroepiandrosterone sulfates within 6 weeks before Day 1.
  • Chronic use of oral glucocorticoid receptor antagonists or cortisol synthesis inhibitors within12 weeks before Day 1.
  • Biotin within 72 hours of screening.
  • Megestrol Acetate within 6 weeks before Day 1
  • Current treatment with any medication that may lead to Maculopathy (see Table 3)
  • Any medication that alters sodium and/or potassium levels (see Table Prohibited Therapy)
  • 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]) > 36 seconds, 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:
  • subchondral insufficiency fractures
  • spontaneous osteonecrosis of the knee
  • osteonecrosis
  • 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.
  • Evidence of pigmentary maculopathy identified by a retinal specialist during Screening.
  • Morning Cortisol ≤ 3 µg/dL.
  • ACTH <10 pg/ml; Morning Cortisol >3 µg/dL and <10 µg/dL and peak cortisol (by ACTH stimulation test) <18 µg/dL.
  • 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.
  • 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.

Trial locations and contacts

33 sites in 2 countries.

33 sites in 2 countries

United States29 sites

  • FutureSearch Trials - Austin

    Austin, Texas, 78731

  • Core Healthcare Group

    Cerritos, California, 90703

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Clinical Research of West Florida- Clearwater

    Clearwater, Florida, 33765

  • University Clinical Research-Deland

    DeLand, Florida, 32720

  • Alliance for Multispecialty Research - Knoxville

    Knoxville, Tennessee, 37909

  • Biosolutions Clinical Research Center

    La Mesa, California, 91942

  • Alliance for Multispecialty Research - Las Vegas

    Las Vegas, Nevada, 89119

  • Kaplan Medical Research

    Las Vegas, Nevada, 89119

  • Tandem Clinical Research

    Marrero, Louisiana, 77072

  • LMG Research

    Miami, Florida, 33125

  • Well Pharma Medical Research, Corp.

    Miami, Florida, 33173

  • Alliance for Multispecialty Research - Newton

    Newton, Kansas, 67114

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Clinical Investigations of Texas

    Plano, Texas, 75075

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Prospective Research Innovations Inc.

    Rancho Cucamonga, California, 91730

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Diagnostics Research Group - Northwest San Antonio

    San Antonio, Texas, 78229

  • Discovery Clinical Trials

    San Antonio, Texas, 78258

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Clinical Research of West Florida

    Tampa, Florida, 33606

  • Alliance for Multispecialty Research - Tempe

    Tempe, Arizona, 85281

  • Fiel Family and Sports Medicine

    Tempe, Arizona, 85283

  • Tucson Orthopaedic Institute

    Tucson, Arizona, 85712

  • Alliance for Multispecialty Research - Wichita West

    Wichita, Kansas, 67205

  • Alliance for Multispecialty Research - Wichita East

    Wichita, Kansas, 67207

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

Australia4 sites

  • Australian Clinical Research Network

    Maroubra, New South Wales, 2035

  • Linear Clinical Research Limited

    Nedlands, Western Australia, 6009

  • Griffith University

    Southport, Queensland, 4222

  • Sportsmed

    Stepney, South Australia, 5069

Other trials in Australia

About this study

Official title: A 2-stage, Adaptive, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate Dose and Treatment Effect of Pentosan Polysulfate Sodium Compared With Placebo in Participants With Knee Osteoarthritis Pain

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 osteoarthritis pain.

Study details include:

  • The study duration will be up to 31 weeks per participant
  • The treatment duration will be 6 weeks.
  • The visit frequency will be twice weekly during treatment.
  • The visit frequency will be every 4 weeks during the follow-up period.
Read the 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:

  • 1.5 mg/kg calculated for ideal body weight (IBW) PPS twice weekly
  • 2 mg/kg IBW PPS once weekly + placebo once weekly
  • 100/150/180 mg PPS if ≤ 65 kg/ ≥ 65 kg and ≤ 90kg/ > 90kg IBW+ 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 31 weeks, which includes:

  • 7-week Screening Period from Day -45 to Day -1
  • 6-week Treatment Period from Day 1 to Day 39
  • 18-week Follow-up Period from Day 40 to Day 168
Being tested
Pentosan Polysulfate Sodium twice weekly, Placebo (Sodium Chloride Injection, 0.9%), Pentosan Polysulfate Sodium Fixed Dose, Pentosan Polysulfate Sodium once weekly
Keywords
Osteoarthritis, Knee
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pentosan Polysulfate Sodium twice weeklyDrug

    Also called PPS twice weekly

    Subcutaneous Injection, 1.5mg/kg Ideal body Weight (IBW)

  • Placebo (Sodium Chloride Injection, 0.9%)Drug

    Also called Placebo

    Placebo to match PPS

  • Pentosan Polysulfate Sodium Fixed DoseDrug

    Also called Fixed Dose

    Subcutaneous Injection, 100/150/180 mg if <65kg/ ≥ 65 kg and ≤ 90kg/ >90 kg IBW

  • Pentosan Polysulfate Sodium once weeklyDrug

    Also called PPS once weekly

    Subcutaneous Injection, 2.0mg/kg Ideal body Weight (IBW)

Study groups in NCT04809376
Study groupRoleWhat they receive
PPS Twice WeeklyExperimentalPentosan Polysulfate Sodium (PPS) twice weekly for 6 weeks
Receives: Drug: Pentosan Polysulfate Sodium twice weekly
PPS Once WeeklyExperimentalPentosan Polysulfate Sodium (PPS) + placebo once weekly for 6 weeks
Receives: Drug: Placebo (Sodium Chloride Injection, 0.9%); Drug: Pentosan Polysulfate Sodium once weekly
PPS Fixed Dose Once WeeklyExperimentalPentosan Polysulfate Sodium (PPS) Fixed dose (100mg,150mg, or 180mg) once weekly + placebo once weekly for 6 weeks
Receives: Drug: Placebo (Sodium Chloride Injection, 0.9%); Drug: Pentosan Polysulfate Sodium Fixed Dose
PlaceboPlacebo comparatorPlacebo twice weekly for 6 weeks
Receives: Drug: Placebo (Sodium Chloride Injection, 0.9%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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.

    Measured: Baseline, Day 56

Secondary outcomes (22)

  1. Key secondary: Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index

    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.

    Measured: Baseline to Day 56

  2. Key secondary: Change from baseline at Day 84 in knee pain as assessed by the average pain subscale score of the WOMAC NRS 3.1 Index

    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.

    Measured: Baseline to Day 84

  3. Key secondary: Change from baseline at Day 84 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index

    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.

    Measured: Baseline to Day 84

  4. Stage 1 only: Change from baseline at Day 56 and 84 in knee pain as assessed by the average pain subscale score of the WOMAC NRS 3.1 Index for PPS 1.5 mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly

    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.

    Measured: Baseline to Day 56 and Day 84

  5. Stage 1 only: Reduction in knee pain of ≥ 30% and ≥ 50% as assessed by the average pain subscale score of the WOMAC NRS 3.1 Index at Days 56 and 84 for PPS 1.5mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly

    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.

    Measured: Baseline to Day 56 and Day 84

  6. Stage 1 only: Stage 1 only: Change from baseline at Day 56 and 84 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index for PPS 1.5 mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly

    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.

    Measured: Baseline to Day 56 and Day 84

  7. Stage 1 only: Improvement in function of ≥ 30% and ≥ 50% as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index at Days 56 and 84 for PPS 1.5mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly

    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.

    Measured: Baseline to Day 56 and Day 84

  8. Stage 1 only: PGIC scores at Days 56 and 84 for PPS 1.5mg/kg twice weekly, PPS 2.0mg/kg once weekly, and PPS fixed dose once weekly

    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".

    Measured: Baseline to Day 56 and Day 84

  9. Stage 1 and 2: Outcomes Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index response rate at 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).

    Measured: Baseline, Days 39, 56, 84, 112, 140 and 168

  10. Stage 1 and 2: Change from baseline at Days 11, 25, 39, 112, 140 and 168 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index.

    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.

    Measured: Baseline, Days 11, 25, 39, 112, 140 and 168

  11. Stage 1 and 2: Change from baseline in knee pain of >=30% and >=50% as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Days 11, 25, 39, 112, 140, and 168

    Percentage of participants with reduction in WOMAC pain intensity of at least >=30% 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.

    Measured: Baseline, Days 11, 25, 39, 112, 140 and 168

  12. Stage 1 and 2: Change from baseline at Days 11, 25, 39, 112, 140 and 168 in function as assessed by the average functional sub-scale score of the WOMAC® Index.

    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.

    Measured: Baseline, Days 11, 25, 39, 112, 140 and 168

  13. Stage 1 and 2: Improvement in function of >=30% 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

    Percentage of participants with improvement in WOMAC function of at least >=30% 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.

    Measured: Baseline, Days 11, 25, 39, 112, 140, and 168

  14. Stage 1 and 2: 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

    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.

    Measured: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168

  15. Stage 1 and 2: 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

    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.

    Measured: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168

  16. Stage 1 and 2: 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)

    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.

    Measured: Baseline, Days 11, 25, 39, 56, 84, 112, 140, and 168

  17. Stage 1 and 2: PGIC scores at Days 39, 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".

    Measured: Baseline, Days 39, 112, 140, and 168

  18. Stage 1 and 2: Change from baseline at Days 56, 84, 112, 140, and 168 in Work Productivity and Activity Impairment (WPAI) questionnaire score

    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.

    Measured: Baseline, Day 56, 84, 112, 140 and 168

  19. Stage 1 and 2: Number of days of rescue medication used from Day 1 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

    Measured: Baseline up to Day 168

  20. Stage 1 and 2: Incidence of treatment-emergent Adverse Event (TEAEs), including serious AEs (SAEs)

    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.

    Measured: Baseline up to Day 168

  21. Stage 1 and 2: Treatment-emergent clinical laboratory abnormalities

    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

    Measured: Baseline up to Day 168

  22. Stage 1 and 2: Clinically significant changes in electrocardiograms (ECG) compared with baseline (pharmacokinetic [PK] subset only)

    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.

    Measured: Baseline, Day 1, Day 15, Day 36 and Day 39

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study start19 Oct 2021
  3. Primary completion15 Oct 2024 (estimated)
  4. Study completion6 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04809376
Sponsor's protocol ID
PARA_OA_002
Status last verified
Apr 2024
First submitted
18 Mar 2021
Last updated
8 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Pentosan Polysulfate Sodium twice weekly, Pentosan Polysulfate Sodium Fixed Dose and Pentosan Polysulfate Sodium once weekly in people with Osteoarthritis, Knee, run by Paradigm Biopharmaceuticals USA (INC) at 33 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04809376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in