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The purpose of this study is to determine if a single or repeat intra-articular injection of Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gel-200 | Device | Single Intra-articular Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200 | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore) | Observed WOMAC pain subscore on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain. Improved score from baseline to week 13 were calculated as baseline minus week 13. | Baseline and Week 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SKK | Plantation | Florida | 33324 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29780263 | Derived | Takamura J, Seo T, Strand V. A Pooled Analysis of Two Multicenter, Randomized Controlled Trials of a Single Intra-articular Injection of Gel-200 for Treatment of Osteoarthritis of the Knee. Clin Med Insights Arthritis Musculoskelet Disord. 2018 May 9;11:1179544118773068. doi: 10.1177/1179544118773068. eCollection 2018. | |
| 27250845 |
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A total of 202 patients were entered.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2Gel-200 | Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint. |
| FG001 | 1PBS1Gel-200 | Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2Gel-200 | Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint. |
| BG001 |
| 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 | Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200 | Posted | Number | participants | 13 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 | 2Gel-200 | Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Dept. | Seikagaku Corporation | 81-3-5220-8950 | hiroyuki.hosokawa@seikagaku.co.jp |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Improvement From Baseline in WOMAC VAS (Stiffness Subscore) | Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Improved score from baseline to week 13 were calculated as baseline minus week 13. | Baseline and Week 13 |
| Improvement From Baseline in WOMAC VAS (Physical Function Subscore) | Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Improved score from baseline to week 13 were calculated as baseline minus week 13. | Baseline and Week 13 |
| Improvement From Baseline in WOMAC VAS (Total Score) | Observed all WOMAC mean scores on Visual Analog Scale (VAS) of 100 mm; a total of WOMAC pain, stiffness, and physical function subscores. Improved score from baseline to week 13 were calculated as baseline minus week 13. | Baseline and Week 13 |
| Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response | Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by improvements from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders). | Weeks 13 |
| Improvement From Baseline in Subject Global Evaluations | Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13. | Baseline and Week 13 |
| Improvement From Baseline in Physician Global Evaluations | Observed physician evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13. | Baseline and Week 13 |
| Acetaminophen Consumption | Weekly mean acetaminophen consumption between weeks 9 and 13. | Week 9 to Week 13 |
| Strand V, Lim S, Takamura J. Evidence for safety of retreatment with a single intra-articular injection of Gel-200 for treatment of osteoarthritis of the knee from the double-blind pivotal and open-label retreatment clinical trials. BMC Musculoskelet Disord. 2016 Jun 1;17:240. doi: 10.1186/s12891-016-1101-0. |
| Lost to Follow-up |
|
| Others |
|
| 1PBS1Gel-200 |
Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms/meters square |
|
| WOMAC VAS Pain Subscore | Assessed Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) pain subscores on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain. | Mean | Standard Deviation | Scores on a scale |
|
| WOMAC VAS Stiffness Subscore | Assessed Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) stiffness subscores on VAS of 100 mm.; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. | Mean | Standard Deviation | scores on a scale |
|
| WOMAC VAS Physical Function Subcore | Assessed Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) physical function subscores on VAS of 100 mm.; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. | Mean | Standard Deviation | scores on a scale |
|
| WOMAC VAS Total Score | Mean of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) pain, stiffness and physical function subscores on VAS of 100 mm.; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. | Mean | Standard Deviation | scores on a scale |
|
| Subject Global Evaluations | Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm.; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. | Mean | Standard Deviation | scores on a scale |
|
| Physician Global Evaluations | Observed physician evaluations on Visual Analog Scale (VAS) of 100 mm.; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. | Mean | Standard Deviation | scores on a scale |
|
|
|
|
| Secondary | Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore) | Observed WOMAC pain subscore on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain. Improved score from baseline to week 13 were calculated as baseline minus week 13. | ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA. | Posted | Mean | Standard Deviation | millimeters | Baseline and Week 13 |
|
|
|
|
| Secondary | Improvement From Baseline in WOMAC VAS (Stiffness Subscore) | Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Improved score from baseline to week 13 were calculated as baseline minus week 13. | ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA. | Posted | Mean | Standard Deviation | millimeters | Baseline and Week 13 |
|
|
|
|
| Secondary | Improvement From Baseline in WOMAC VAS (Physical Function Subscore) | Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Improved score from baseline to week 13 were calculated as baseline minus week 13. | ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA. | Posted | Mean | Standard Deviation | millimeters | Baseline and Week 13 |
|
|
|
|
| Secondary | Improvement From Baseline in WOMAC VAS (Total Score) | Observed all WOMAC mean scores on Visual Analog Scale (VAS) of 100 mm; a total of WOMAC pain, stiffness, and physical function subscores. Improved score from baseline to week 13 were calculated as baseline minus week 13. | ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA. | Posted | Mean | Standard Deviation | millimeters | Baseline and Week 13 |
|
|
|
|
| Secondary | Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response | Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by improvements from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders). | ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA. | Posted | Number | Percentage of Participants | Weeks 13 |
|
|
|
| Secondary | Improvement From Baseline in Subject Global Evaluations | Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13. | ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA. | Posted | Mean | Standard Deviation | millimeters | Baseline and Week 13 |
|
|
|
|
| Secondary | Improvement From Baseline in Physician Global Evaluations | Observed physician evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13. | ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA. | Posted | Mean | Standard Deviation | millimeters | Baseline and Week 13 |
|
|
|
|
| Secondary | Acetaminophen Consumption | Weekly mean acetaminophen consumption between weeks 9 and 13. | ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA. | Posted | Mean | Standard Deviation | milligrams | Week 9 to Week 13 |
|
|
|
| 3 |
| 125 |
| 44 |
| 125 |
| EG001 | 1PBS1Gel-200 | Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint. | 1 | 74 | 27 | 74 |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Transient ischemic attack | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
SKK has the right to review the disclosures. Investigator shall not make any publication of study data, results or similar information without the express of permission of SKK.
| D012216 |
| Rheumatic Diseases |
| t-test, 2 sided |
| <0.0001 |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided |
| <0.0001 |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided |
| <0.0001 |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided |
| <0.0001 |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided |
| <0.0001 |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided |
| <0.0001 |
| 95 |
| No |
| Superiority or Other |