Osteoarthritis Clinical Trial
Official title:
Multicenter Double-blind Randomized Comparative Placebo-controlled Study of Efficacy and Safety of Intra-articular Polyacrylamide Hydrogel With Silver Ions (NOLTREX™) in Knee Osteoarthritis
Verified date | March 2020 |
Source | Research Centre BIOFORM |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this double-blinded controlled study is to assess clinical efficacy and safety of intra-articular polyacrylamide hydrogel with ions of silver in comparison with placebo (0.9% sodium chloride solution) in Kellgren Lawrence radiological grade II-III knee osteoarthritis
Status | Active, not recruiting |
Enrollment | 144 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Verified knee osteoarthritis in accordance with the ACR (knee pain combined with one of the following signs: age above 50 years, knee crepitus or morning joint stiffness lasting for less than 30 minutes combined with radiologic signs of knee osteoarthritis); - Kellgren Lawrence radiological grade II-III knee osteoarthritis with the predominant involvement of the medial tibiofemoral region of the knee joint; - Joint space width (JSW) of the target knee joint at least 2.5 mm. Exclusion Criteria: 1. History of any injury or surgical intervention on the target knee joint (except for diagnostic arthroscopy made not longer than 60 days at the study entry); 2. Severe degenerative changes in the target knee joint determined as the joint space narrowing less than 2 mm; 3. Varus or valgus deformation of the target knee joint; 4. Instability of the target knee joint; 5. Active inflammation of the target knee joint (edema, hyperemia, present effusion) at the study entry; 6. Microcrystalline arthropathies; 7. Systemic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, etc.); 8. Seronegative spondyloarthritis and reactive arthritis; 9. Inflammatory diseases of the skin and soft tissues in the proposed injection site for the test MD or placebo in the target joint; 10. History of venous thrombosis and thromboembolia; 11. Coagulogram abnormalities (APTT, prothrombin time, prothrombin index, fibrinogen); 12. Inflammatory changes in the complete blood count (leukocytosis, increase of erythrocyte sedimentation rate [ESR]); 13. Platelet count abnormality (in accordance with the reference ranges of the local laboratory; 14. Increase of rheumatoid factor level; 15. Increase of uric acid level > 360 µmol/l; 16. Diabetes mellitus; 17. Hemophilia and other hemorrhagic diatheses, as well administration of anticoagulants and disaggregants; 18. Positive results of HIV, HBs-Ag, anti-HCV, RW tests; 19. Intra-articular injection to the target knee joint: - Noltrex - within 24 months prior patient's inclusion to the study; - hyaluronates - within 6 months prior patient's inclusion to the study; - glucocorticosteroids - within 1 month prior the study inclusion; - non-steroidal anti-inflammatory drugs (NSAID) - within 3 weeks prior patient's inclusion to the study. 20. Oral administration of non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks prior the study inclusion; 21. Necessity of systemic glucocorticosteroids in any dosage form; 22. Paracetamol administration within 48 hours prior the study inclusion; 23. Pregnancy and lactation; 24. Hypersensitivity to components of the test MD or placebo; 25. Severe liver disorder determined as the increase of one of the values: ALT, AST, ALP, total bilirubin, GGTP more than 3 times the upper limit of normal; 26. Renal diseases with the glomerular filtration rate estimated per Cockraft-Gault formula less than 60 ml/min/1.73 m2 (III-V stage chronic renal disease [CRD]); 27. Clinically manifest hip osteoarthritis; 28. History of knee and coxofemoral endoprosthesis; 29. Acute infectious diseases or infectious aggravations of chronic diseases (respiratory infections) within one month prior the study inclusion; 30. Severe decompensated chronic or acute diseases and other conditions which, by the opinion of the study physician, may preclude the patient's participation in the study or affect the study results. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Non-budgetary healthcare facility "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways" | Moscow | |
Russian Federation | "Clinical Diagnostic Center "Ultramed", LLC | Omsk | |
Russian Federation | Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg | Saint Petersburg | |
Russian Federation | State budgetary healthcare facility of Yaroslavl Region "Clinical hospital ?3" | Yaroslavl |
Lead Sponsor | Collaborator |
---|---|
Research Centre BIOFORM |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of the total WOMAC score (WOMAC-T) | Estimated per the corresponding subscales and total arthritis index score developed by WOMAC | at Week 25 in comparison with baseline at Week 1 | |
Secondary | The total score | Change of the total score of WOMAC scale (WOMAC-T) | at Week 13 in comparison with baseline at Week 1 | |
Secondary | The pain | Change of the pain subscale score (WOMAC-A) | at Week 6, Week 13 and Week 25 and in comparison with baseline at Week 1 | |
Secondary | The rigidity and functionality | Change of rigidity (WOMAC-B) and functionality (WOMAC-C) subscale scores | at Week 6, Week 13 and Week 25 and in comparison with baseline at Week 1 | |
Secondary | Patient's assessment of the treatment efficacy | per scale from 1 - evident aggravation to 6 - significant improvement | Week 6, Week 13 and Week 25 | |
Secondary | Investigator's assessment of the treatment efficacy | per scale from 1 - evident aggravation to 6 - significant improvement | Week 6, Week 13 and Week 25 | |
Secondary | Assessment of the total number of paracetamol tablets taken | the need in paracetamol intake to relieve the knee pain during administration of intra-articular MD NOLTREX™ in comparison with placebo | Week 6, Week 13 and Week 25 | |
Secondary | Patient withdrawal rates due to safety | Proportion of patient who left the study due to: Need in paracetamol intake due to knee osteoarthritis 4 days a week and more during 2 successive weeks; The investigator makes the decision that a patient should discontinue the study in the best interests of the patient; Individual intolerability or contraindications to the test MD, placebo or paracetamol; AE/SAE which requires examination and/or treatment affecting significantly the study procedures (in particular, in particular, development of active arthritis or hemarthrosis of the target knee joint). |
Week 25 | |
Secondary | Patient withdrawal rates due to poor patient's treatment compliance | Proportion of patient who left the study due to: Informed consent withdrawal (patient's unwillingness to continue the study); Major deviation from the study protocol. |
Week 25 | |
Secondary | Intensity of pain in the target knee joint (100-mm VAS) | Assessment of pain intensity in the target knee joint per mm visual analogous scale (100-mm VAS) | Week 1, Week 2 |
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