Osteoarthritis, Knee
Conditions
Interventions
Patient with knee osteoarthritis is subcutaneously administered NaPPS or placebo once a week for 8 weeks (8 times in total), and the dose is 2 mg/kg of body weight. Patient should be administered to t
Sponsors
Matsumoto Tadashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)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. 2)Patients who are able to talk (to explain or indicate their symptoms) 3)Patients aged >=40 years and <75 years at the time of informed consent 4)Japanese patients living in Japan
Exclusion criteria
Exclusion criteria: 1)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 2)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 3)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 4)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. 5)Patients who received the drugs or therapies in the other clinical trials within 16 weeks prior to obtaining informed consent 6)Patients who used heparin (excluding heparin analogues) or a polysulfate pentosan preparation within 16 weeks prior to obtaining informed consent 7)Patients who received platelet-rich plasma (PRP) therapy of the knee joint within 24 weeks prior to obtaining informed consent 8)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 9)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) 10)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) 11)Patients who used acetaminophen (including use as a rescue medication) within 2 days prior to the tentative enrollment assessment date (Visit1) 12)Patients who used supplements containing hyaluronan, glucosamine, chondroitin, collagen, and proteoglycans within 4 weeks prio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC-A (mean points on the sections): pain in 48 hours (the evaluated knee) 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage improved based on OMERACT-OARSI Responder Criteria | — |
Contacts
Public ContactTomotsugu Kubo
ReqMed Company, Ltd.
Outcome results
None listed