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CompletedPhase 1ACTRN12619000047190

Pentosan Polysulphate (PPS) for Dyslipidaemia in Knee Osteoarthritis

Sponsor

University of Sydney

Enrollment

38 participants

Start Date

Feb 22, 2019

Study Type

Interventional

Conditions

OsteoarthritisDyslipidaemia

Summary

This study aims to determine whether oral delivery of PPS drug will lower lipid levels in patients with knee OA. We are also interested to investigate if the improvement in dyslipidaemia might lead to improving OA symptoms and slowing disease progression, as measured by function, pain and MRI, in patients with mild to moderate knee osteoarthritis.

Eligibility

Sex: Both males and femalesMin Age: 45 Yearss

Inclusion Criteria11

  • A. Male or female patients minimum of 45 years or more;
  • B. Are able to give written informed consent and to participate fully in the interventions and follow-up procedures including travel to the Royal North Shore Hospital;
  • C. Have history of primary hypercholesterolemia and total fasting cholesterol above 5.0mmol/L at screening;
  • D. Have any symptoms associated with OA of the knee for at least 6 months prior to screening visit and confirmation of OA based on the clinical and radiological criteria of American College of Rheumatology Criteria for OA (Altman et al, 1986) of the knee prior or at screening.
  • E. Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee based on knee radiograph performed at screening or within six months of the screening visit;
  • F. Have Index knee pain on most days over the last month.
  • G. Knee Pain Severity Scale above 4 using an 11-point (0-10) numerical severity scale where 0 is no pain at all and 10 is worst possible pain in the last 48 hours at baseline visit;
  • (If both knees are affected by OA then the most symptomatic knee will be considered the index knee. If both knees are equally affected, the index knee will be determined by the Investigator.)
  • H. BMI<40 kg/m2 at screening visit;
  • I. Agree to maintain their usual activity level and diet throughout the study;
  • J. Female of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation;

Exclusion Criteria24

  • A. Documented history of Fibromyalgia, Reiter’s syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease;
  • B. Known hypersensitivity to Pentosan Polysulfate or related compounds (e.g. heparin);
  • C. Any unstable concurrent clinically significant acute, chronic medical conditions or abnormal laboratory findings that, in the judgment of the Investigator, would jeopardise the safety of the patient, interfere with the objectives of the protocol, or affect the patients compliance with the study requirements, as determined by the investigator;
  • D. Contraindications for MRI including but not limited to pacemaker, metal sutures, presence of shrapnel, or claustrophobia;
  • E. Current or a recent history (within last 12 months) of bleeding (a gastric or duodenal ulcer or suspicion of GI tract bleeding) or menorrhagia;
  • F. Haemophilia ;
  • G. Planned / anticipated invasive procedure (or surgery) within 6 months;
  • H. Recent surgery;
  • I. Bilateral Knee replacement
  • J. Concurrent heparin or oral anti-coagulant therapy;
  • K. Concurrent therapy with lipid –modifying drugs for hypercholesterolemia;
  • L. Female patients who are pregnant, nursing or intend to get pregnant;
  • M. Use of prohibited pain medication( see below)
  • Oral non-steroidal anti-inflammatory drugs (NSAIDs)
  • Aspirin (>325 mg per day)
  • Centrally-acting pain medications (e.g., pregabalin, gabapentin, duloxetine)
  • Opioids (e.g. tramadol)
  • Topical therapies (e.g., NSAIDs ) applied to the index knee
  • Muscle relaxants (e.g. tetrazepam, diazepam)
  • N. Prohibited Concomitant Medications:
  • Lipid-modifying drugs: statins ( e.g. atorvastatin, pravastatin and simvastatin) or ezetimibe (Ezetrol)
  • Anticoagulants including heparin, warfarin, apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto)
  • Biological/ disease –modifying anti-rheumatic drugs for arthritis
  • Steroid drugs for systematic use

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Interventions

100 mg oral Pentosan polysulphate Capsules calculated as per 10 mg per 1 Kg body weight.for e.g 5 capsules if weight =50-55 Kg, 6 capsules if weight=55-60 Kg Capsules taken once every 4th day Monit

100 mg oral Pentosan polysulphate Capsules calculated as per 10 mg per 1 Kg body weight.for e.g 5 capsules if weight =50-55 Kg, 6 capsules if weight=55-60 Kg Capsules taken once every 4th day Monitoring of the Intervention - Paper Diary and e diary through a mobile app (both Android and ios phones)

Locations(1)

Royal North Shore Hospital - St Leonards

NSW, Australia

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ACTRN12619000047190

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