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The aim of this double-blinded controlled study is to assess clinical efficacy and safety of intra-articular HBISA Endoprosthesis of Synovial Fluid (polyacrylamide hydrogel) in comparison with placebo (0.9% sodium chloride solution) in Kellgren Lawrence radiological grade II-III knee osteoarthritis
Polyacrylamide hydrogel (hereinafter - PAAG) is intended for a symptomatic effect leading to decrease of joint pain intensity and improvement of functional joint characteristics. Therefore PAAG is regarded as symptom-modifying therapy for joint osteoarthritis (hereinafter - OA). The aim of this study was to estimate efficacy and safety of intra-articular injections of PAAG in comparison with saline solution. Men and women above 50 years with verified knee osteoarthritis in accordance with the American College of Rheumatology (ACR) criteria were randomly assigned to one of 2 groups (PAAG or saline solution). Each patient received to the target knee joint one injection of 4.0 ml either PAAG or placebo with one-week interval. Course - 2 injections. To avoid the joint overfilling with the dense, slowly resorbing material in patients with a good clinical result, the course of injections was to be stopped. Primary and secondary efficacy endpoints, and safety parameters were assessed at weeks 6, 13 and 25 visits .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOLTREX™, OA grade II-III | Experimental | 72 patients with gonarthrosis grade II-III were randomised to receive PAHG |
|
| Placebo,OA grade II-III | Placebo Comparator | 72 patients with gonarthrosis grade II-III were randomised to receive saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrous biopolymer with silver ions "Argiform" | Device | 2 once-weekly intra-articular injections of NOLTREX™ 4.0 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Total WOMAC Score (WOMAC-T) | Mean change from baseline (week 1) to visit 5 (Week 25) in the total WOMAC score. Patients were asked to complete the questionnaire during the study visit 5. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-500 for Pain, 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales gives a total WOMAC score (0-2400), where 0 represents the best health status and 2400 the worst possible status. The higher the score, the poorer the function. | baseline (week 1), week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Total WOMAC Score (WOMAC-T) | Mean change from baseline (week 1) to Week 13 in the total WOMAC score. Patients were asked to complete the questionnaire during the study visits 1, 3, 4, 5. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales gives a total WOMAC score (0-96), where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function. |
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Inclusion Criteria:
Exclusion Criteria:
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);
Severe degenerative changes in the target knee joint determined as the joint space narrowing less than 2 mm;
Varus or valgus deformation of the target knee joint;
Instability of the target knee joint;
Active inflammation of the target knee joint (edema, hyperemia, present effusion) at the study entry;
Microcrystalline arthropathies;
Systemic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, etc.);
Seronegative spondyloarthritis and reactive arthritis;
Inflammatory diseases of the skin and soft tissues in the proposed injection site for the test MD or placebo in the target joint;
History of venous thrombosis and thromboembolia;
Coagulogram abnormalities (APTT, prothrombin time, prothrombin index, fibrinogen);
Inflammatory changes in the complete blood count (leukocytosis, increase of erythrocyte sedimentation rate [ESR]);
Platelet count abnormality (in accordance with the reference ranges of the local laboratory;
Increase of rheumatoid factor level;
Increase of uric acid level > 360 μmol/l;
Diabetes mellitus;
Hemophilia and other hemorrhagic diatheses, as well administration of anticoagulants and disaggregants;
Positive results of HIV, HBs-Ag, anti-HCV, RW tests;
Intra-articular injection to the target knee joint:
Oral administration of non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks prior the study inclusion;
Necessity of systemic glucocorticosteroids in any dosage form;
Paracetamol administration within 48 hours prior the study inclusion;
Pregnancy and lactation;
Hypersensitivity to components of the test MD or placebo;
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;
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]);
Clinically manifest hip osteoarthritis;
History of knee and coxofemoral endoprosthesis;
Acute infectious diseases or infectious aggravations of chronic diseases (respiratory infections) within one month prior the study inclusion;
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.
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir V Popov, DSc | Non-budgetary HCF "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Non-budgetary healthcare facility "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways" | Moscow | Russia | ||||
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7 patients were classified as "screen failure" and 144 patients were randomized (1:1) to receive NOLTREX™ (n = 72) or placebo (n = 72).
151 patients were selected for the study, of which 144 were randomised at 4 study sites from November 2019 to November 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | NOLTREX™, OA Grade II-III | 72 patients with knee osteoarthritis grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits |
| FG001 | Placebo, ОА Grade II-III | Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographic and baseline characteristics were described by treatment group in the ITT population (all randomized patients who received at least one dose of study intervention)
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| ID | Title | Description |
|---|---|---|
| BG000 | NOLTREX™, OA Grade II-III | Patients with osteoarthritis Grade II-III received 2 weekly injections of the PAHG hydrous biopolymer with silver ions "Argiform" 4.0 ml (NOLTREX™) at the week 1 and 2 study visits. |
| BG001 | Placebo, OA Grade II-III |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of the Total WOMAC Score (WOMAC-T) | Mean change from baseline (week 1) to visit 5 (Week 25) in the total WOMAC score. Patients were asked to complete the questionnaire during the study visit 5. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-500 for Pain, 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales gives a total WOMAC score (0-2400), where 0 represents the best health status and 2400 the worst possible status. The higher the score, the poorer the function. | The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline (week 1), week 25 |
|
1 year From 29-Nov-2019 to 17-Nov-2020
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NOLTREX™, II-III Grade OA | patients with II-III grade of gonarthrosis will randomised to receive PAHG hydrous biopolymer with silver ions "Argiform": 4.0 ml for one injection with one-week interval between injections. Course - 2 injections. In NOLTREX™ Group, 5 AEs occurred in 2 (2.78%) patients, and none of them was described as SAE. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| community-acquired bilateral polysegmental pneumonia caused by coronavirus infection COVID-19 | Infections and infestations | MedDRA SOC | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Lower back pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Melentyeva Commercial Director | RCBIOFORM | +7 (495) 223-70-95 | md@bioform.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2020 | Nov 1, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2020 | Nov 1, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000028 | Abortion, Induced |
| ID | Term |
|---|---|
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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multicenter double-blind randomized comparative placebo-controlled
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A patient, study investigator and Sponsor representative (monitoring specialist) will not know to which group a patient is included. to preserve blinding of any patient and study team, an independent unblended physician is to be engaged, he/she will receive the product per randomization code and perform the procedure of intra-articular injection of the study MD and placebo.
| saline solution | Device | 2 once-weekly intra-articular injections of saline solution 4 ml |
|
| baseline (week 1), week 13 (visit 4) |
| The Pain Subscale Score WOMAC-A Changes | Mean change from baseline (week 1) to week 6 (visit 3), 13 (visit 4) and 25 (visit 5) in the WOMAC Pain score (WOMAC-A). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standardized questionnaires used by health professionals to evaluate pain, stiffness and physical functioning of the joints in patients with knee and/or hip osteoarthritis. The WOMAC Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS. The WOMAC pain scale consists of five items: (1) walking on flat ground; (2) going up or down stairs; (3) at night while in bed; (4) sitting or lying; and (5) standing upright. The scores for the Pain subscale are summed up, with a possible score range of 0-500. Higher scores represent worse pain. Patients were asked to complete the questionnaire during the study visits 1, 3, 4, 5. | baseline (week 1), week 6 (visit 3), 13 (visit 4) and 25 (visit 5) |
| The Stiffness (WOMAC-B) and Functionality (WOMAC-C) Subscale Scores Changes | Mean change from baseline (week 1) to week 6 (visit 3), 13 (visit 4) and 25 (visit 5) in the WOMAC Stiffness (WOMAC-B) and WOMAC Physical Function (WOMAC-C) scores. Patients were asked to complete the questionnaire during the study visit 5. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse stiffness and functional limitations. The higher the score, the poorer the function. | baseline (week 1), week 6 (visit 3), 13 (visit 4) and 25 (visit 5) |
| Patient Assessment of Treatment Efficacy | Patient satisfaction with treatment was measured by a 6-point scale Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 6), 4 (week 13) and 5 (week 25). | Week 6, Week 13 and Week 25 |
| Investigator Assessment of Treatment Efficacy | Investigator satisfaction with treatment was measured by a 6-point scale Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 6), 4 (week 13) and 5 (week 25). | Week 6, Week 13 and Week 25 |
| Assessment of the Total Number of NSAID Tablets Taken | A patient diary was used to capture data about the number of NSAID Tablets Taken. In case of paracetamol ineffectiveness and pain persistence patient was allowed to take Protocol-permitted NSAID in certain doses. | week 6 (visit 3), week 13 (visit 4), week 25 (visit 5) |
| Assessment of the Total Number of Paracetamol Tablets Taken | A patient diary was used to capture data about the number of paracetamol tablets taken. | week 6 (visit 3), week 13 (visit 4), week 25 (visit 5) |
| Patient Exclusion Rates Due to Safety | According to protocol the reasons for withdrawal included health status deterioration, investigator's decision, need in paracetamol use ≥4 days a week during 2 consecutive weeks, individual intolerance or contraindications to the study MD, placebo, paracetamol or any of the protocol-permitted NSAIDs; development of a AE/SAE requiring examination and/or treatment that can significantly affect the study procedures | Week 25 |
| Exclusion Rate Due to Poor Patient Compliance | According to the protocol the reasons for patients drop-out included major protocol deviations (poor compliance) and withdrawal of informed consent. | Week 25 |
| "Clinical Diagnostic Center "Ultramed", LLC |
| Omsk |
| Russia |
| Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg | Saint Petersburg | Russia |
| State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3" | Yaroslavl | Russia |
Patients with osteoarthritis Grade II-III received 2 weekly injections of the saline solution (placebo) at the week 1 and 2 study visits. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG000 | NOLTREX™, OA Grade II-III | Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of PAAG (NOLTREX™) 4.0 ml at the week 1 and 2 study visits. |
| OG001 | Placebo, ОА Grade II-III | Patients with osteoarthritis Grade II-III received 2 weekly intra-articular injections of the saline solution (placebo) at the week 1 and 2 study visits. |
|
|
|
| Secondary | Change of the Total WOMAC Score (WOMAC-T) | Mean change from baseline (week 1) to Week 13 in the total WOMAC score. Patients were asked to complete the questionnaire during the study visits 1, 3, 4, 5. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales gives a total WOMAC score (0-96), where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function. | The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline (week 1), week 13 (visit 4) |
|
|
|
|
| Secondary | The Pain Subscale Score WOMAC-A Changes | Mean change from baseline (week 1) to week 6 (visit 3), 13 (visit 4) and 25 (visit 5) in the WOMAC Pain score (WOMAC-A). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standardized questionnaires used by health professionals to evaluate pain, stiffness and physical functioning of the joints in patients with knee and/or hip osteoarthritis. The WOMAC Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS. The WOMAC pain scale consists of five items: (1) walking on flat ground; (2) going up or down stairs; (3) at night while in bed; (4) sitting or lying; and (5) standing upright. The scores for the Pain subscale are summed up, with a possible score range of 0-500. Higher scores represent worse pain. Patients were asked to complete the questionnaire during the study visits 1, 3, 4, 5. | The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline (week 1), week 6 (visit 3), 13 (visit 4) and 25 (visit 5) |
|
|
|
|
| Secondary | The Stiffness (WOMAC-B) and Functionality (WOMAC-C) Subscale Scores Changes | Mean change from baseline (week 1) to week 6 (visit 3), 13 (visit 4) and 25 (visit 5) in the WOMAC Stiffness (WOMAC-B) and WOMAC Physical Function (WOMAC-C) scores. Patients were asked to complete the questionnaire during the study visit 5. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse stiffness and functional limitations. The higher the score, the poorer the function. | The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline (week 1), week 6 (visit 3), 13 (visit 4) and 25 (visit 5) |
|
|
|
|
| Secondary | Patient Assessment of Treatment Efficacy | Patient satisfaction with treatment was measured by a 6-point scale Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 6), 4 (week 13) and 5 (week 25). | The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention). | Posted | Number | 95% Confidence Interval | participants | Week 6, Week 13 and Week 25 |
|
|
|
|
| Secondary | Investigator Assessment of Treatment Efficacy | Investigator satisfaction with treatment was measured by a 6-point scale Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 6), 4 (week 13) and 5 (week 25). | The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention). | Posted | Number | 95% Confidence Interval | participants | Week 6, Week 13 and Week 25 |
|
|
|
|
| Secondary | Assessment of the Total Number of NSAID Tablets Taken | A patient diary was used to capture data about the number of NSAID Tablets Taken. In case of paracetamol ineffectiveness and pain persistence patient was allowed to take Protocol-permitted NSAID in certain doses. | The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention). | Posted | Number | Number of NSAID tablets | week 6 (visit 3), week 13 (visit 4), week 25 (visit 5) |
|
|
|
| Secondary | Assessment of the Total Number of Paracetamol Tablets Taken | A patient diary was used to capture data about the number of paracetamol tablets taken. | The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention). The mean number of tablets was calculated taking into account only patients who had received paracetamol. | Posted | Mean | Standard Deviation | mean number of paracetamol taken | week 6 (visit 3), week 13 (visit 4), week 25 (visit 5) |
|
|
|
|
| Secondary | Patient Exclusion Rates Due to Safety | According to protocol the reasons for withdrawal included health status deterioration, investigator's decision, need in paracetamol use ≥4 days a week during 2 consecutive weeks, individual intolerance or contraindications to the study MD, placebo, paracetamol or any of the protocol-permitted NSAIDs; development of a AE/SAE requiring examination and/or treatment that can significantly affect the study procedures | The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention). | Posted | Number | 95% Confidence Interval | participants | Week 25 |
|
|
|
| Secondary | Exclusion Rate Due to Poor Patient Compliance | According to the protocol the reasons for patients drop-out included major protocol deviations (poor compliance) and withdrawal of informed consent. | The intent-to-treat (ITT) population (all randomized patients who received at least one dose of study intervention). | Posted | Number | 95% Confidence Interval | participants | Week 25 |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 5 |
| 72 |
| EG001 | Placebo, II-III Grade ОА | patients with II-III grade of gonarthrosis will randomised to receive saline solution saline solution: 4.0 ml for one injection with one-week interval between injections. Course - 2 injections. In Placebo Group, 11 AEs occurred in 2 (2.78%) of patients, of them, in 1 (1.39%) patient SAE was registered. | 0 | 72 | 1 | 72 | 11 | 72 |
|
| Community-acquired bilateral polysegmental pneumonia caused by coronavirus infection COVID-19 | Infections and infestations | MedDRA SOC | Systematic Assessment |
|
|
| Lumbar spine pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Stomach ache | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| General weakness. | General disorders | Systematic Assessment |
|
| A sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Runny nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Superiority |
[Not specified] |
| Week 25 |
|
| Contrasts for changes in pain WOMAC score at visit 4 (week 13) | ANCOVA | Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of "treatment group" and "radiological stage" | 0.00847 | The threshold for statistical significance was p <0.05. | LS-means difference | -26.695 | Standard Error of the Mean | 9.995 | 2-Sided | 95 | -46.46 | -6.93 | Superiority |
| Contrasts for changes in pain WOMAC score at visit 5 (week 25) | ANCOVA | Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of "treatment group" and "radiological stage" | 0.00123 | The threshold for statistical significance was p <0.05. | LS-means difference | -33.96 | Standard Error of the Mean | 10.29 | 2-Sided | 95 | -54.31 | -13.62 | Superiority |
| WOMAC-B /Week 25 |
|
| WOMAC-C /Week 6 |
|
| WOMAC-C /Week 13 |
|
| WOMAC-C /Week 25 |
|
| Contrasts for changes in stiffness WOMAC score, visit 4 | ANCOVA | Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of "treatment group" and "radiological stage" | 0.00693 | The threshold for statistical significance was p <0.05. | LS-means difference | -14.50 | Standard Error of the Mean | 5.29 | 2-Sided | 95 | -24.95 | -4.04 | Superiority |
| Contrasts for changes in pain WOMAC score at visit 5 (week 25) | ANCOVA | Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of "treatment group" and "radiological stage" | 0.00073 | The threshold for statistical significance was p <0.05. | LS-means difference | -16.18 | Standard Error of the Mean | 4.68 | 2-Sided | 95 | -25.44 | -6.92 | Superiority |
| Contrasts for changes in functionality WOMAC score, visit 3 | ANCOVA | Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of "treatment group" and "radiological stage" | 0.07725 | The threshold for statistical significance was p <0.05. | LS-means difference | -57.14 | Standard Error of the Mean | 32.10 | 2-Sided | 95 | -120.62 | 6.33 | Superiority |
| Contrasts for changes in functionality WOMAC score, visit 4 | ANCOVA | Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of "treatment group" and "radiological stage" | 0.00279 | The threshold for statistical significance was p <0.05. | LS-means difference | -103.27 | Standard Error of the Mean | 33.92 | 2-Sided | 95 | -170.35 | -36.20 | Superiority |
| Contrasts for changes in functionality WOMAC score, visit 5 | ANCOVA | Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of "treatment group" and "radiological stage" | 0.00023 | The threshold for statistical significance was p <0.05. | LS-means difference | -133.29 | Standard Error of the Mean | 35.26 | 2-Sided | 95 | -203.03 | -63.55 | Superiority |
| Week 6,aggravation |
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| Week 6, without changes |
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| Week 6, weak improvement |
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| Week 6, improvement |
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| Week 6, significant improvement |
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| Week 13,evident aggravation |
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| Week 13,aggravation |
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| Week 13, without changes |
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| Week 13, weak improvement |
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| Week 13, improvement |
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| Week 13, significant improvement |
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| Week 25,evident aggravation |
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| Week 25, aggravation |
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| Week 25, without changes |
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| Week 25, weak improvement |
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| Week 25, improvement |
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| Week 25, significant improvement |
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| Week 6,aggravation |
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| Week 6, without changes |
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| Week 6, weak improvement |
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| Week 6, improvement |
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| Week 6, significant improvement |
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| Week 13,evident aggravation |
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| Week 13,aggravation |
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| Week 13, without changes |
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| Week 13, weak improvement |
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| Week 13, improvement |
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| Week 13, significant improvement |
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| Week 25, evident aggravation |
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| Week 25, aggravation |
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| Week 25, without changes |
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| Week 25, weak improvement |
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| Week 25, improvement |
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| Week 25, significant improvement |
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| Week 25 |
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The mean number of paracetamol tablets was calculated taking into account only patients who had received paracetamol. ANCOVA was used to detect a difference in means of 2 groups at visit 4 (week 13). |
| ANCOVA |
| 0.004 |
The threshold for statistical significance was p <0.05. |
| Superiority |