CTIS2022-500228-31-01进行中（未招募）1 期
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 - PARA_OA_002
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 938
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male and Female Participants 18 years of age or older, Clinical diagnosis of OA in the index knee by American College of Rheumatology 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 to conservative therapy for =6 months preceding Screening, Average WOMAC® NRS 3.1 Index pain subscale score of 4 to 10 in the index knee at Screening AND a minimum pain score of 4 on either of the individual questions of pain on walking on a flat surface or pain on climbing stairs at Screening., Average WOMAC® NRS 3.1 Index function subscale score of 4 to 10 in the index knee at Screening., Body mass index of =18.0 to =39.0 kg/m2, 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.
排除标准
- •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., 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), Gilberts syndrome, uncontrolled diabetes and uncontrolled hypothyroidism or hyperthyroidism, or mental or emotional disorders that preclude reliable study participation., Current treatment with anticoagulants or antiplatelet drugs, excluding aspirin =100 mg/day., Previous treatment with PPS in any form., 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, 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)., Major surgery or anticipated surgery during the study., 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, Fibromyalgia 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 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.
研究者
相似试验
进行中（未招募）
1 期
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 PaiKnee osteoarthritis painMedDRA version: 21.1Level: LLTClassification code: 10023476Term: Knee osteoarthritis Class: 10028395CTIS2022-500228-31-00Paradigm Biopharmaceuticals (USA) Inc.898
招募中
1 期
An adaptive, Phase 2, double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-7104.056 in patients with early stages of Parkinson’s diseaseEarly stages of idiopathic Parkinson's DiseaseMedDRA version: 20.0Level: PTClassification code: 10061536Term: Parkinson's disease Class: 100000004852CTIS2022-500292-31-00AC Immune S.A.150
Unknown
2 期
Safety, Pharmacokinetics, Pharmacodynamics and Efficacy study of MRG-001 on Severe and Critical SARS-CoV-2CTRI/2022/01/039274Medregen LLC
招募中
不适用
A Two-Part, Adaptive, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) Study to Evaluate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Intravenous and Intramuscular GM-2505 in Healthy VolunteersdepressionMajor depressive disorder10027946NL-OMON56273Gilgamesh Pharmaceuticals84
已完成
2 期
A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)Colitis, Ulcerative-JPRN-jRCT2031200403Masaki Takeshi20