Randomized, double-blind, placebo-controlled, multi-center study assessing the efficacy, and safety of subcutaneous administration regimens of NaPPS versus placebo in patients with knee osteoarthritis

Matsumoto Tadashi0 个研究点目标入组 90 人开始时间: 2022年3月9日最近更新: 2024年4月1日

适应症

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 90

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 40age old 至 < 75age old（—）
性别: All

入选标准

•[At the time of provisional registration]
•1) Patients diagnosed with knee osteoarthritis (hereinafter referred to as OA) according to the ACR classification criteria, excluding secondary OA, with standing frontal radiographic findings of grade 2 or higher on the K-L classification in the knee to be evaluated or both knees.
•2) Patients with OA pain in the knee to be evaluated for at least one year prior to the provisional registration evaluation date (Visit 1), and the pain persists despite the use of drug therapy including regenerative medicine products.
•3) WOMAC-A (pain) score and 50-foot (15-meter) walk test score are between NRS 5 and 9 for the evaluated knee and 3 or less for the non-evaluated knee.
•WOMAC-A score: The average of the responses in Section A.
•4) One or more of the four clinical findings of tenderness (medial articular facet, lateral articular facet, patellofemoral joint, and popliteal area) is observed in the knee to be evaluated.
•5) Patient capable of conversation (able to explain or express their symptoms)
•6) Age from 40 to less than 75 years old at the time of consent.
•7) Patients who are expected to be able to perform all the observation items planned in the clinical trial and who agree to the implementation.
•8) Patients who have agreed to follow the instructions of the investigator.
•9) Patients who understand the purpose of the clinical trial and the study, understand the side effects, and have given written consent to participate in the clinical trial.
•10) Japanese patients residing in Japan
•[At the time of registration]
•1) Patients whose WOMAC-A score during pre-administration observation and at the time of registration is between NRS 5 and 9 for the evaluated knee and 3 or less for the non-evaluated knee.
•2) Patients whose WOMAC-A scores of the evaluated knee during pre-dose observation and at the time of enrollment are stable within +-20% of the score at the time of provisional registration.
•3) Patients with at least one of the four clinical findings of tenderness (medial articular facet, lateral articular facet, patellofemoral joint, and popliteal area) in the knee to be evaluated.

排除标准

•[At the time of provisional registration]
•1) Patients with any of the following complications
•(1) Patients with a predisposition to bleeding (gastrointestinal bleeding such as gastric ulcer, duodenal ulcer, etc., or patients with suspected cerebral hemorrhage)
•(2) Patients whose complications pose a therapeutic or safety problem due to the prohibition of concomitant administration of prohibited drugs during the period of administration of the investigational drug
•(3) Patients with cardiovascular diseases (e.g., aneurysms) or hematological diseases (e.g., thrombocytopenia) that may pose a bleeding risk
•(4) Patients with heparin-induced thrombocytopenia (HIT) type II
•(5) Patients with serious allergic diseases or serious complications
•(6) Patients with keloid diathesis
•(7) Patients with complications or suspicious findings of maculopathy.
•2) Patients with a history of any of the following
•(1) Patients with a history of drug hypersensitivity to heparin or pentosan polysulfate
•(2) Patients with a history of HIT type II
•(3) Patients with a history of drug hypersensitivity or thrombocytopenia
•(4) Patients with a history of severe food allergy
•(5) Patients with a history of malignant tumor (except for patients who have not had metastasis or recurrence since complete resection and no treatment is required, and more than 5 years have passed as of the date of provisional registration)
•3) Patients whose AST >100 IU/L, ALT >100 IU/L, or APTT values exceed the upper limit of the institutional reference values
•4) Patients who have undergone a surgical procedure within 6 months (24 weeks) prior to obtaining consent, or are scheduled to undergo a surgical procedure during the study period
•5) Patients who have participated in other clinical studies or clinical trials within 4 months (16 weeks) prior to obtaining consent, or who have used heparin or polysulfated pentosan products
•6) Patients who have participated in the treatment or clinical trial of a regenerative medicine product within one year prior to obtaining consent.
•7) Patients who have got platelet-rich plasma (PRP) therapy to the knee joint within 6 months (24 weeks) prior to obtaining consent.
•8) Patients who received intra-articular administration of hyaluronic acid to the evaluated knee, systemic or intra-articular corticosteroid administration to the evaluated knee (excluding injection or topical application to other than the evaluated knee, or topical use such as inhalation or application) within 1 month (4 weeks) prior to the provisional registration evaluation date (Visit 1).
•9) Patients who have received non-steroidal anti-inflammatory drugs (except for topical use other than the knees to be evaluated), acetaminophen (other than oral), muscle relaxants, narcotic analgesics, non-narcotic analgesics, drugs indicated for pain, or chondroitin products (except for ophthalmic use) within 7 days prior to the provisional registration evaluation date (Visit 1)
•10) Patients who have taken oral acetaminophen within 2 days prior to the provisional registration evaluation date (Visit 1).
•11) Patients who have taken supplements containing hyaluronic acid, glucosamine, chondroitin, or collagen since obtaining consent
•12) Patients with significant functional impairment of the lower limb on the knee side to be evaluated due to fracture, trauma, etc.
•13) Patients whose body weight exceeds 100 kg
•14) Patients with alcoholism or drug dependence
•15) Pregnant or lactating patients, or patients of childbeari

研究者

发起方

Matsumoto Tadashi

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