Pentosan Polysulfate Sodium for Osteoarthritis, Knee

1
Effectiveness
2
Safety
Clinical Trials of Texas, Inc., San Antonio, TX
Osteoarthritis, Knee+1 More
Pentosan Polysulfate Sodium - Drug
Eligibility
18+
All Sexes
Eligible conditions
Osteoarthritis, Knee

Study Summary

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

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Eligible Conditions

  • Osteoarthritis, Knee
  • Arthrosis
  • Osteoarthritis

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Pentosan Polysulfate Sodium will improve 1 primary outcome, 36 secondary outcomes, and 16 other outcomes in patients with Osteoarthritis, Knee. Measurement will happen over the course of Baseline to Day 56.

Baseline to Day 56
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
Day 84
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
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
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
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
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
Baseline to Day 84
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
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
Day 168
Incidence of Treatment-emergent clinical laboratory abnormalities upto end of study
Incidence of treatment-emergent Adverse Event (TEAEs), including serious AEs (SAEs) upto end of study
Number of days of rescue medication used from Day 1 to Day 168
Stage 1 and 2: Incidence of treatment-emergent Adverse Event (TEAEs), including serious AEs (SAEs)
Stage 1 and 2: Number of days of rescue medication used from Day 1 to Day 168
Stage 1 and 2: Treatment-emergent clinical laboratory abnormalities
Day 39
Incidence of clinically significant changes in electrocardiograms (ECG) compared with baseline at Day 15 and 39
Day 39
Stage 1 and 2: Clinically significant changes in electrocardiograms (ECG) compared with baseline (pharmacokinetic [PK] subset only)
Baseline, Day 56
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.
Day 56
Change from baseline at Days 56, 84, 112, 140, and 168 in Work Productivity and Activity Impairment (WPAI) questionnaire score
Stage 1 and 2: Change from baseline at Days 56, 84, 112, 140, and 168 in Work Productivity and Activity Impairment (WPAI) questionnaire score
Day 11
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
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.
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.
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
Day 11
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
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
Day 11
Exporatory: Number of participants with an Anti-Drug-Antibody (ADA) response after treatment
Number of participants with an Anti-Drug-Antibody (ADA) response at Days 11, 25, 39, 56 and 84
Day 11
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.
Day 11
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)
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
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
PGIC scores at Days 39, 56, 84 112, 140, and 168
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)
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
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
Day 11
Exploratory: Correlation of Anti-Drug-Antibody (ADA) response with clinical events
Day 11
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.
Day 39
Stage 1 and 2: PGIC scores at Days 39, 112, 140, and 168
Day 39
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
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
Day 4
Exploratory: PPS PK profile of single and multiple doses based on sparse blood sampling
Stage 1: Change in PPS plasma concentration over time of single and multiple doses at Days 1, 15 and 39
Day 4
Stage 2: Change in PPS plasma concentration over time of single and multiple doses at Days 1, 15 and 39
screening, Day 168
Exploratory: Change in bone shape on MRI from baseline at Day 168
Exploratory: Change in cartilage volume on MRI from baseline at Day 168
Exploratory: Change in joint space width on MRI from baseline at Day 168
Exploratory: Change in subchondral BML area and volume on MRI from baseline at Day 168
Exploratory: Changes in joint synovitis/effusion volume on MRI from baseline on Day 168
Exploratory: The effect of PPS on bone shape changes and whether these correlate with clinical outcomes
Exploratory: The effect of PPS on cartilage volume changes on MRI and whether these correlate with clinical outcomes
Exploratory: The effect of PPS on joint space width changes and whether these correlate with clinical outcomes
Exploratory: The effect of PPS on joint synovitis/effusion volume on MRI and whether these correlate with clinical outcomes
Exploratory: The effect of PPS on subchondral BML volume and area on MRI and whether these changes correlate with clinical outcomes

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

4 Treatment Groups

Placebo
PPS Once Weekly
Placebo group

This trial requires 938 total participants across 4 different treatment groups

This trial involves 4 different treatments. Pentosan Polysulfate Sodium is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

PPS Once WeeklyPentosan Polysulfate Sodium (PPS) + placebo once weekly for 6 weeks
PPS Fixed Dose Once WeeklyPentosan Polysulfate Sodium (PPS) Fixed dose (100mg,150mg, or 180mg) once weekly + placebo once weekly for 6 weeks
PPS Twice WeeklyPentosan Polysulfate Sodium (PPS) twice weekly for 6 weeks
Placebo
Drug
Placebo twice weekly for 6 weeks

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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 for reporting.

Closest Location

Clinical Trials of Texas, Inc. - San Antonio, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participant must be >= 18 years of age inclusive, at the time of signing the informed consent.
You have a clinical diagnosis of OA in the index knee by ACR criteria 1986. show original
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.
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;
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.
Body mass index of >=18 to <=35.0 kg/m2
You are female of childbearing potential and you must agree to comply with the protocol specified contraceptive requirements. show original
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.
You have 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. show original
You have an average WOMAC NRS score of 4 to 10 in the index knee at Screening and Day 1. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for osteoarthritis, knee?

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Knee replacements are rarely used to treat only knee pain. Other treatments include conservative treatments such as NSAIDs and pain management (including non-opioid alternatives and physical therapy) or oral, intra-articular, or extra-articular modalities, such as a variety of medications and surgery. Non-steroidal anti-inflammatory drugs are recommended over paracetamol for low-quality evidence as initial treatments for osteoarthritis of the knee. Other non-opioid medications are only recommended if NSAIDs do not provide sufficient relief in certain types of osteoarthritis.

Unverified Answer

How many people get osteoarthritis, knee a year in the United States?

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around 25 million people in the United States have [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis) of the knee, of which around 11% has clinical knee OA (symptoms and/or signs) on radiography.

Unverified Answer

What causes osteoarthritis, knee?

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Obesity, age, body weight, gender, knee joint effusion, and knee osteophyte formation may affect knee cartilage destruction, which is the main cause of knee OA. Knee joint effusion may also play an important role in knee cartilage destruction in obese people with knee OA.

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Can osteoarthritis, knee be cured?

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Knee OA, not knee joint space narrowing (KSW), can be cured following arthroscopic lavage with 1% lidocaine solution or 1.2% lidocaine gel. It is essential to know that knee joint space narrowing (KSW) cannot be cured to prevent further knee OA.

Unverified Answer

What is osteoarthritis, knee?

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The knee is a joint that sits sideways on the thigh. It is important to pay attention to the position of the knee when walking or doing daily activities. Damage to the knee knee can result in osteoarthritis and this can cause pain, stiffness and limitation of joint movement. This article helps us to understand osteoarthritis and helps us to detect early signs and signs of its onset. Osteoarthritis also can be treated and this article helps us to do it.

Unverified Answer

What are the signs of osteoarthritis, knee?

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All five of the signs of knee osteoarthritis were common and were present in every patient at some stage of their disease. The most common signs were stiffness (74%) and joint space narrowing or bowing (45%). The knee should be assessed by palpation, range of motion or in the squatting position, so that symptoms can be detected early and treatment adjusted accordingly. Since all of these signs are present early in untreated knee osteoarthritis, early diagnosis is an important factor in the management of the disease.

Unverified Answer

What are the latest developments in pentosan polysulfate sodium for therapeutic use?

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A recent trial has revealed that PPSS shows positive effects on a broad spectrum of illnesses such as rheumatoid joints, psoriasis, and other inflammatory diseases.\nTo date, there has been little research or clinical study, however, involving the use of PPSS in the treatment of osteoarthritis.\nAs of today, there are no clear indications for the use of PPSS in treatment of osteoarthritis. However, there is still a lack of a large-randomized, double-blind, placebo-controlled study that is designed to examine the use of PPSS over time in regard to disease progression in osteoarthritis of the knee.

Unverified Answer

What is the average age someone gets osteoarthritis, knee?

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Osteoarthritis often begins in one joint(ies) and spreads quickly between adjacent joints. Osteoarthritis causes pain, stiffness, and swelling in the knee. [Osteoarthritis.org] This disease and its symptoms are common among older adults, but there are no studies done specifically investigating the prevalence of this disease in a younger group. The average age when the knee begins to show signs of osteoarthritis is about age 65.\n\nThe [U.S government.] Centers for Disease Control and Prevention (CDC) is responsible for reporting and investigating health problems in the U.S.

Unverified Answer

Is pentosan polysulfate sodium typically used in combination with any other treatments?

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SPS is seldom the sole OA treatment being used. Physicians frequently use SPS with NSAIDs, bisphosphonates, or corticosteroids, and often with additional anti-inflammatory drugs. In some respects, SPS acts as an adjunct because in combination with NSAIDs it may slow the progression of disease and improve pain relief.

Unverified Answer

What does pentosan polysulfate sodium usually treat?

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PPS does not seem effective in improving the pain of chronic hip OA for 2 months. We were unable to observe benefits to a greater extent than placebo after 4 months of treatment.

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How serious can osteoarthritis, knee be?

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We found that moderate to severe knee OA has a major influence on the QoL and SF-12 in women, but not in men. Since moderate to severe knee OA was not associated with greater radiographical joint space narrowing, more research is required to confirm whether moderate to severe knee OA will lead to the development of patellofemoral pain syndrome. In addition to severity criteria, osteophytestes should be used more often as an indicator of disease severity.

Unverified Answer

What are the common side effects of pentosan polysulfate sodium?

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The most common side effects in this trial were nausea (5.6% of patients) and diarrhea (4.5% of patients). Numbness, dizziness, and increased appetite were also fairly common.

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