jRCT2071210131进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 主要终点
- WOMAC - Overall Score
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
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 40age old over 至 75age old not（—）
- 性别
- All
入选标准
- •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.
- •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.
- •Patients with confirmed the pain above a certain level in the knee to be evaluated by a survey and no or low pain in the non-evaluated knee.
- •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.
- •Patient capable of conversation (able to explain or express their symptoms)
- •Age from 40 to less than 75 years old at the time of consent.
- •Patients who are expected to be able to perform all the observation items planned in the clinical trial and who agree to the implementation.
- •Patients who have agreed to follow the instructions of the investigator.
- •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.
- •Japanese patients residing in Japan
排除标准
- •[At the time of provisional registration]
- •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.
- •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)
- •Patients whose AST >100 IU/L, ALT >100 IU/L, or APTT values exceed the upper limit of the institutional reference values
- •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
- •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
- •Patients who have participated in the treatment or clinical trial of a regenerative medicine product within one year prior to obtaining consent.
- •Patients who have got platelet-rich plasma (PRP) therapy to the knee joint within 6 months (24 weeks) prior to obtaining consent.
- •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).
- •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)
- •Patients who have taken oral acetaminophen within 2 days prior to the provisional registration evaluation date (Visit 1).
- •Patients who have taken supplements containing hyaluronic acid, glucosamine, chondroitin, or collagen since obtaining consent
- •Patients with significant functional impairment of the lower limb on the knee side to be evaluated due to fracture, trauma, etc.
- •Patients whose body weight exceeds 100 kg
- •Patients with alcoholism or drug dependence
- •Pregnant or lactating patients, or patients of childbearing potential who wish to become pregnant during the study period, or patients who are unable to consent to appropriate contraception (intrauterine device, spermicide, condom application by partner, etc.) (Pregnancy testing will be required at the time of registration and at defined time points during the study period)
- •Patients with a history of participation in the study (including participation in the observation period only)
- •Other patients who are judged by the investigator to have difficulty in answering or filling in the questionnaires necessary for the evaluation of the efficacy of the study or who are not appropriate for the safe conduct of the study.
- •[At the time of registration]
- •Patients whose APTT exceeded the upper limit of the institutional reference value in the APTT study up to the day before registration.
- •Patients who become pregnant before enrollment
- •Patients who are found to meet any of the exclusion criteria at the time of provisional registration by the time of registration.
结局指标
主要结局
WOMAC - Overall Score
时间窗: Visit 9 and Visit 11 compared to Visit 3
Evaluation using a questionnaire format to be completed by the patient. The questions are divided into three sections as follows - Section A: Pain within 48 hours - Section B: Stiffness - Section C: Difficulty in performing daily activities The total score of the three sections is the WOMAC overall score.
次要结局
未报告次要终点
研究者
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