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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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The purpose of this study is to determine the comparative safety and efficacy of intra-articular injection of hyaluronic acid, obtained from two different sources, in the treatment of osteoarthritic pain of the knee.
This is a multicenter, randomized, double blind, parallel-controlled clinical trial using a non-inferiority comparison to evaluate the efficacy and safety of an intra-articular injection of Durolane® vs Artz® in the treatment of knee osteoarthritis. Subjects will be randomized 1:1 to receive either Durolane or Artz. All subjects will be followed up for 26 weeks from the initial treatment.The screening period is expected to be up to 2 weeks in duration before the baseline visit. Each subject will provide a written informed consent and undergo a qualifying screening. Assessment at screening will include postero-anterior view of standing weight-bearing semi-flexed radiographs of the study knee. The osteoarthritis changes of the study knee will be graded 0,1,2,3 or 4 according to the Kellgren-Lawrence radiographic scoring criteria. Radiographic assessment will be made by an assigned and well trained investigator at each study center. The study knee and contralateral knee will use the Likert WOMAC 5-point scoring for pain assessment.
Physical examination of the knees and vital signs will be performed (this examination will be repeated at end).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARTZ sodium hyaluronate | Active Comparator | The comparator product, ARTZ, is manufactured by Seikagaku Corporation, Japan. Subjects randomized to the ARTZ group were administered five weekly intra-articular injections (2.5 ml, NASHA 25 mg). ARTZ is a sterile, viscoelastic nonpyrogenic solution of purified, high molecular weight (620,000-1,170,000 daltons) sodium hyaluronate having a pH of 6.8-7.8. The sodium hyaluronate is extracted from chicken combs. |
|
| DUROLANE hyaluronic acid | Active Comparator | The investigational product was provided in pre-filled syringes containing stabilized non-animal hyaluronic acid (20 mg/mL). Only one injection was given for those subjects randomized to the DUROLANE group, followed by 4 sham injections. DUROLANE is free from products of animal origin and is manufactured by Q-Med AB Corporation.The sham injection procedure was same as the active injection, except that they were subcutaneous and an empty syringe was used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARTZ | Device | Hyaluronic acid (five 2.5 mL injections) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline | Pain assessment is made of 5 items; each has 5 possible values 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The items are summed for a total range of 0 to 20. Therefore, the pain change from baseline range is -20 to 20. A negative change is a reduction in pain from the baseline pain score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | over 18 weeks (week timepoints 6, 10, 14, and 18) |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline | Pain assessment is made of 5 items; each has 5 possible values 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The items are summed for a total range of 0 to 20. Therefore, the pain change from baseline range is -20 to 20. A negative change is a reduction in pain from the baseline pain score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianhao Lin, MD | People Hospital of Beijing University No. 11 South Ave., Xizhimen, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Frienship Hospital | Beijing | China | ||||
| Beijing General Military Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25889322 | Result | Zhang H, Zhang K, Zhang X, Zhu Z, Yan S, Sun T, Guo A, Jones J, Steen RG, Shan B, Zhang J, Lin J. Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz. Arthritis Res Ther. 2015 Mar 10;17(1):51. doi: 10.1186/s13075-015-0557-x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ARTZ | ARTZ: Hyaluronic acid (five 2.5 mL injections) |
| FG001 | DUROLANE | DUROLANE: Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ARTZ | ARTZ: Hyaluronic acid (five 2.5 mL injections) |
| BG001 | DUROLANE | DUROLANE: Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections) |
| 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 | WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline | Pain assessment is made of 5 items; each has 5 possible values 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The items are summed for a total range of 0 to 20. Therefore, the pain change from baseline range is -20 to 20. A negative change is a reduction in pain from the baseline pain score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | per protocol: all subjects randomized and treated with no important protocol deviation(s), which were established at a blinded data review meeting. An important deviation is any deviation that has the potential to bias the primary outcome. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | over 18 weeks (week timepoints 6, 10, 14, and 18) |
26 weeks
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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 | ARTZ | ARTZ: Hyaluronic acid (five 2.5 mL injections) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Regulatory and Clinical Affairs | Bioventus, LLC | 1-800-396-4325 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Investigational product was masked from study staff and participants with the exception of the unblinded treating investigator conducting the intra-articular injections.
| DUROLANE |
| Device |
Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections) |
|
| over 26 weeks (week 6, 10, 14, 18, and 26) |
| WOMAC (Western Ontario and McMaster Osteoarthritis Index) Physical Function Subscale Change From Baseline | Physical Function assessment is made of 17 items; each has 5 possible values 0=none, 1=mild, 3=moderate, 4=extreme. The items are summed for a total range of 0 to 68. Therefore, the physical function change from baseline range is -68 to 68. A negative change is an improvement in physical function from the baseline physical function score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | over 18 weeks (week timepoints 6, 10, 14, and 18) |
| WOMAC (Western Ontario and McMaster Osteoarthritis Index) Physical Function Subscale Change From Baseline | Physical Function assessment is made of 17 items; each has 5 possible values 0=none, 1=mild, 3=moderate, 4=extreme. The items are summed for a total range of 0 to 68. Therefore, the physical function change from baseline range is -68 to 68. A negative change is an improvement in physical function from the baseline physical function score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | over 26 weeks (week timepoints 6, 10, 14, 18, and 26) |
| Subject Global Assessment Change From Baseline | Subject global assessment is one question "Considering all the ways your knee osteoarthritis affects you, how are you doing today?". It has 11 values 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 labeled only at the extremes; 0 = very bad and 10 = very good. The change from baseline range is -10 to 10. A positive change is an improvement from the baseline subject global assessment score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | over 18 weeks (week timepoints 6, 10, 14, and 18) |
| Subject Global Assessment Change From Baseline | Subject global assessment is one question "Considering all the ways your knee osteoarthritis affects you, how are you doing today?". It has 11 values 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 labeled only at the extremes; 0 = very bad and 10 = very good. The change from baseline range is -10 to 10. A positive change is an improvement from the baseline subject global assessment score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | over 26 weeks (week timepoints 6, 10, 14, 18, and 26) |
| WOMAC (Western Ontario and McMaster Osteoarthritis Index) Knee Stiffness Subscale Change From Baseline | Knee stiffness assessment is made of 2 items; each has 5 possible values 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The items are summed for a total range of 0 to 8. Therefore, the knee stiffness change from baseline range is -8 to 8. A negative change is a reduction in knee stiffness from the baseline knee stiffness score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | over 18 weeks (week timepoints 6, 10, 14, and 18) |
| WOMAC (Western Ontario and McMaster Osteoarthritis Index) Knee Stiffness Subscale Change From Baseline | Knee stiffness assessment is made of 2 items; each has 5 possible values 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The items are summed for a total range of 0 to 8. Therefore, the knee stiffness change from baseline range is -8 to 8. A negative change is a reduction in knee stiffness from the baseline knee stiffness score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | over 26 weeks (week timepoints 6, 10, 14, 18, and 26) |
| Beijing |
| China |
| Beijing University #3 Hospital | Beijing | China |
| Beijing University People's Hospital | Beijing | China |
| Zhejiang #2 Hospital | Hangzhou | China |
| Shanghai #6 People's Hospital | Shanghai | China |
| Shanghai #9 People's Hospital | Shanghai | China |
| Adverse Event |
|
| Lost to Follow-up |
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| Lack of Efficacy |
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| Other: inconvenience |
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| Other: family objection |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | ARTZ | ARTZ: Hyaluronic acid (five 2.5 mL injections) |
| OG001 | DUROLANE | DUROLANE: Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections) |
|
|
|
| Secondary | WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline | Pain assessment is made of 5 items; each has 5 possible values 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The items are summed for a total range of 0 to 20. Therefore, the pain change from baseline range is -20 to 20. A negative change is a reduction in pain from the baseline pain score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | per protocol: all subjects randomized and treated with no important protocol deviation(s), which were established at a blinded data review meeting. An important deviation is any deviation that has the potential to bias the primary outcome. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | over 26 weeks (week 6, 10, 14, 18, and 26) |
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|
|
|
| Secondary | WOMAC (Western Ontario and McMaster Osteoarthritis Index) Physical Function Subscale Change From Baseline | Physical Function assessment is made of 17 items; each has 5 possible values 0=none, 1=mild, 3=moderate, 4=extreme. The items are summed for a total range of 0 to 68. Therefore, the physical function change from baseline range is -68 to 68. A negative change is an improvement in physical function from the baseline physical function score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | per protocol: all subjects randomized and treated with no important protocol deviation(s), which were established at a blinded data review meeting. An important deviation is any deviation that has the potential to bias the primary outcome. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | over 18 weeks (week timepoints 6, 10, 14, and 18) |
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|
|
| Secondary | WOMAC (Western Ontario and McMaster Osteoarthritis Index) Physical Function Subscale Change From Baseline | Physical Function assessment is made of 17 items; each has 5 possible values 0=none, 1=mild, 3=moderate, 4=extreme. The items are summed for a total range of 0 to 68. Therefore, the physical function change from baseline range is -68 to 68. A negative change is an improvement in physical function from the baseline physical function score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | per protocol: all subjects randomized and treated with no important protocol deviation(s), which were established at a blinded data review meeting. An important deviation is any deviation that has the potential to bias the primary outcome. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | over 26 weeks (week timepoints 6, 10, 14, 18, and 26) |
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|
|
| Secondary | Subject Global Assessment Change From Baseline | Subject global assessment is one question "Considering all the ways your knee osteoarthritis affects you, how are you doing today?". It has 11 values 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 labeled only at the extremes; 0 = very bad and 10 = very good. The change from baseline range is -10 to 10. A positive change is an improvement from the baseline subject global assessment score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | per protocol: all subjects randomized and treated with no important protocol deviation(s), which were established at a blinded data review meeting. An important deviation is any deviation that has the potential to bias the primary outcome. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | over 18 weeks (week timepoints 6, 10, 14, and 18) |
|
|
|
|
| Secondary | Subject Global Assessment Change From Baseline | Subject global assessment is one question "Considering all the ways your knee osteoarthritis affects you, how are you doing today?". It has 11 values 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 labeled only at the extremes; 0 = very bad and 10 = very good. The change from baseline range is -10 to 10. A positive change is an improvement from the baseline subject global assessment score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | per protocol: all subjects randomized and treated with no important protocol deviation(s), which were established at a blinded data review meeting. An important deviation is any deviation that has the potential to bias the primary outcome. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | over 26 weeks (week timepoints 6, 10, 14, 18, and 26) |
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|
|
| Secondary | WOMAC (Western Ontario and McMaster Osteoarthritis Index) Knee Stiffness Subscale Change From Baseline | Knee stiffness assessment is made of 2 items; each has 5 possible values 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The items are summed for a total range of 0 to 8. Therefore, the knee stiffness change from baseline range is -8 to 8. A negative change is a reduction in knee stiffness from the baseline knee stiffness score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | per protocol: all subjects randomized and treated with no important protocol deviation(s), which were established at a blinded data review meeting. An important deviation is any deviation that has the potential to bias the primary outcome. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | over 18 weeks (week timepoints 6, 10, 14, and 18) |
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| Secondary | WOMAC (Western Ontario and McMaster Osteoarthritis Index) Knee Stiffness Subscale Change From Baseline | Knee stiffness assessment is made of 2 items; each has 5 possible values 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The items are summed for a total range of 0 to 8. Therefore, the knee stiffness change from baseline range is -8 to 8. A negative change is a reduction in knee stiffness from the baseline knee stiffness score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame". | per protocol: all subjects randomized and treated with no important protocol deviation(s), which were established at a blinded data review meeting. An important deviation is any deviation that has the potential to bias the primary outcome. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | over 26 weeks (week timepoints 6, 10, 14, 18, and 26) |
|
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|
|
| 6 |
| 174 |
| 37 |
| 174 |
| EG001 | DUROLANE | DUROLANE: Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections) | 3 | 175 | 39 | 175 |
| Otitis media | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Meniscus lesion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Colon polypectomy | Surgical and medical procedures | MedDRA 13.1 | Non-systematic Assessment |
|
| Cerebral infarction | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
This is a non-inferiority test. The non-inferiority margin of +1.6 units corresponds to an 8% margin on the pain subscale (range 0-20) |
This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68). |
This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68). |
This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin. |
This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin. |
This is a non-inferiority test. The non-inferiority margin of +0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8). |
This is a non-inferiority test. The non-inferiority margin of 0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8).