jRCT2031250145招募中不适用
A phase III, parallel assignment, multicenter, randomized controlled trial, placebo control trial to assess the efficacy and safety of NaPPS in people with knee-osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 主要终点
- WOMAC-A (mean points on the sections): pain in 48 hours (the evaluated knee)
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 according to ACR classification criteria, among whom grade 2 or grade 3 of K-L classification in one knee or both knees are found in the radiological images of the standing front in patients except for secondary knee osteoarthritis.
- •Patients who are able to talk (to explain or indicate their symptoms)
- •Patients aged >=40 years and <75 years at the time of informed consent
- •Japanese patients living in Japan
排除标准
- •<At the time of provisional registration>
- •Patients with any of the following complications
- •(1) Diseases with hemorrhagic diathesis (gastrointestinal haemorrhages such as gastric ulcer and duodenal ulcer, cerebral hemo
- •(2) Cardiovascular disease associated with a high risk of bleeding (aneurysm, etc.), hematologic disease (thrombocytopenia, etc.) rrhage, etc.)
- •(3) Heparin-induced thrombocytopenia type2
- •(4) Drug hypersensitivity to heparin or pentosan polysulfate
- •(5) Severe allergic disease
- •(6) Maculopathy (including suspected)
- •(7) Malignant tumor
- •(8) Diseases in which problems arise in patient safety or treatment of complications by prohibiting the administration of prohibited concomitant drugs
- •(9) Other diseases considered by the investigator or sub-investigator to have the potential to affect the efficacy or safety evaluation in this study
- •Patients with any of the following
- •(1) Thrombocytopenia (not applicable if the cause is obvious such as due to drug and temporary, and the investigator (or sub-investigator) judge that there are no safety problem)
- •(2) Heparin-induced thrombocytopenia type2
- •(3) Drug hypersensitivity to heparin or pentosan polysulfate
- •(4) Severe drug-induced hypersensitivity
- •(5) Malignancy (not applicable if metastatic or recurrent disease has not occurred after complete resection and treatment is not required, and 5 years or more have passed at the tentative enrollment assessment date (Visit1))
- •(6) Other diseases considered by the investigator or sub-investigator to have the potential to affect the efficacy or safety evaluation in this study
- •Subjects with AST>100 IU/L, ALT>100 IU/L or APTT levels above the upper limit of the reference level of the trial site
- •Patients who have undergone surgery (excluding minimally invasive surgical treatment) within 24 weeks prior to obtaining informed consent or who are scheduled for the study period.
- •Patients who received the drugs or therapies in the other clinical trials within 16 weeks prior to obtaining informed consent
- •Patients who used heparin (excluding heparin analogues) or a polysulfate pentosan preparation within 16 weeks prior to obtaining informed consent
- •Patients who received platelet-rich plasma (PRP) therapy of the knee joint within 24 weeks prior to obtaining informed consent
- •Subjects who have participated in a clinical trial or treatment of regenerative medicine products excluding platelet-rich plasma (PRP) therapy for the knee joint within 1 year prior to obtaining informed consent
- •Subjects who received intra-articular administration of hyaluronic acid to the knee or systemic of corticosteroids or intra-articular administration of corticosteroids within 4 weeks prior to the tentative enrollment assessment date (Visit1)
- •Patients receiving systemic administration of non-steroidal anti-inflammatory drugs or topical administration of topical drugs to the knee (ointment, patch, application, etc.), acetaminophen (excluding use as rescue medication), muscle relaxants, narcotic analgesics, non-narcotic analgesics, other drugs with indications for pain, or chondroitin preparations (excluding ophthalmic preparations) within 7 days prior to the tentative date of registration (Visit1)
- •Patients who used acetaminophen (including use as a rescue medication) within 2 days prior to the tentative enrollment assessment date (Visit1)
- •Patients who used supplements containing hyaluronan, glucosamine, chondroitin, collagen, and proteoglycans within 4 weeks prior to the tentative enrollment assessment date (Visit1)
- •Patients with significant functional impairment due to fracture or injury in the lower extremity of the knee side to be evaluated
- •Patients who weigh more than 100 kg
- •Patients with alcoholism or drug dependence
- •Pregnant women or nursing mothers. Patients of childbearing potential who wish to become pregnant or who do not consent to appropriate contraception during the study period
- •Patients who have received NaPPS investigational products
- •Patients participating in other clinical trials
- •Patients considered by the investigator or sub-investigator who have difficulty completing the survey, 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 by the registration trial (Visit3)
- •Patients who become pregnant by the registration trial (Visit3)
- •Patients who were found to meet any of the exclusion criteria of provisional registration by the registration trial (Visit3)
结局指标
主要结局
WOMAC-A (mean points on the sections): pain in 48 hours (the evaluated knee)
时间窗: 8-week study treatment
The primary endpoint is the amount of change (reduction) of WOMAC-A score from the baseline (Visit3) to the 8-week study treatment (Visit11) in the knees evaluated.
次要结局
未报告次要终点
研究者
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