ACTRN12621000654853招募中2 期
A Double-Blind, RandoMised, Placebo-Controlled Study to Assess theEfficacy and Safety of oRal deliVery of sodium Pentosan Polysulfate (PPS)compared to placebo in participants with symptomatic kneE osteoarthritis(OA) and dysLipidemia (MaRVeL Study)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 o limit（—）
- 性别
- All
入选标准
- •(1)Male or female patients with a minimum of 40 years of age;
- •(2)Are able to give written informed consent (e-consent) and to participate fully in the interventions and follow-up procedures including travel to the Royal North Shore Hospital;
- •(3)Have a history of primary hypercholesterolemia and total fasting cholesterol above 5.0 mmol/L at screening;
- •(4)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;
- •(5)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;
- •(6)Have Index knee pain on most days over the last month.
- •(7)Knee Pain Severity Scale between 4 and 9 (inclusive) 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 24 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.
- •(8)BMI<40 kg/m2 at screening visit;
- •(9)Agree to maintain their usual activity level and diet throughout the study;
- •(10)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;
- •(11) Must have internet access for online surveys;
排除标准
- •E 1Documented history of Fibromyalgia, Reiter’s syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease;
- •E 2 IA injections of cortisone into any joint within 3 months, IA injection of hyaluronic acid, PRP, regenerative medicine, or arthroscopy of the index knee within the last 6 months before screening.
- •E 3Previous PPS therapy in last 6 months;
- •E 4Known hypersensitivity to Pentosan Polysulfate or related compounds (e.g., heparins);
- •E 5Any 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 patient’s compliance with the study requirements, as determined by the investigator;
- •E6 History of lymphoproliferative disease or any known malignancy of any organ system, interfere with the objectives of the protocol or affect the patient's compliance with the study requirements, as determined by the investigator;
- •E 7Contraindications for MRI including but not limited to pacemaker, metal sutures, presence of shrapnel, or claustrophobia;
- •E 8Current or a recent history (within last 12 months) of bleeding (a gastric or duodenal ulcer or suspicion of GI tract bleeding) or menorrhagia;
- •E 9Haemophilia;
- •E 10Planned/anticipated invasive procedure (or surgery) within 6 months;
- •E 11 Any recent surgery (last 3 months)
- •E 12Bilateral total knee replacement
- •E 13Concurrent heparin or oral anticoagulant therapy;
- •E 14Concurrent therapy with lipid-modifying drugs for hypercholesterolemia;
- •E 15Female patients who are pregnant, nursing, or intend to get pregnant;
- •E 16Use of prohibited medications such as:
- •NSAIDS (anti-inflammatory drugs like ibuprofen, Mobic);
- •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 diazepam)
- •lipid-modifying drugs: Statins like Lipitor, atorvastatin, pravastatin and simvastatin) or ezetimibe (Ezeterol);
- •Fenofibrates (e.g Antara, Fenoglide, Lipofen, Lofibra, TriCor, Triglide)
- •Anticoagulants like heparin, warfarin, apixaban (Eliquis), dabigatran (Pradaxa), and rivaroxaban (Xeralto);
- •Biological / disease-modifying anti-rheumatic drugs for arthritis;
- •muscle relaxants like diazepam;
- •Steroid drug for systemic use
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