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The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gel-200 | Experimental |
| |
| PBS | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gel-200 | Device | Single intra-articular injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | Baseline and Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | 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 598 patients were screened.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gel-200 | Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint. |
| FG001 | PBS Placebo | Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gel-200 | Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint. |
| BG001 | PBS Placebo | Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint. |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | ITT population was used for analysis. 2 patients with Gel-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 | scores on a scale | Baseline and Week 13 |
|
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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 | Gel-200 | Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infections | Infections and infestations | 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 |
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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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| Device |
Single intra-articular injection |
|
| Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | Baseline and Week 13 |
| Change From Baseline in WOMAC VAS Total Score | Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | Baseline and Week 13 |
| Outcome Measures in Rheumatology Arthritis 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 changes 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 6 to 13 |
| Change From Baseline in Short Form - 36 (SF-36) | Scored on physical component scale from 0 (negative health) to 100 (positive health). Calculated norm based with a mean of 50 and a standard deviation of 10. | Baseline and Week 13 |
| Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | Baseline and Week 13 |
| Change From Baseline in Physician Global Evaluations | Observed physician global 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | Baseline and Week 13 |
| Acetaminophen Consumption | Weekly mean acetaminophen consumption between weeks 9 and 13. | Weeks 9 to 13 (5 weeks) |
| 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. |
| 22342928 | Derived | Strand V, Baraf HSB, Lavin PT, Lim S, Hosokawa H. A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2012 May;20(5):350-356. doi: 10.1016/j.joca.2012.01.013. Epub 2012 Feb 1. |
| Lost to Follow-up |
|
| Others |
|
| 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 |
|
| PBS Placebo |
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint. |
|
|
|
| Secondary | Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | ITT population was used for analysis. 2 patients with Gel-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 | scores on a scale | Baseline and Week 13 |
|
|
|
|
| Secondary | Change From Baseline in WOMAC VAS Total Score | Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | ITT population was used for analysis. 2 patients with Gel-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 | scores on a scale | Baseline and Week 13 |
|
|
|
|
| Secondary | Outcome Measures in Rheumatology Arthritis 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 changes 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. 2 patients with Gel-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 | Weeks 6 to 13 |
|
|
|
|
| Secondary | Change From Baseline in Short Form - 36 (SF-36) | Scored on physical component scale from 0 (negative health) to 100 (positive health). Calculated norm based with a mean of 50 and a standard deviation of 10. | ITT population was used for analysis. 2 patients with Gel-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 | scores | Baseline and Week 13 |
|
|
|
|
| Primary | Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | ITT population was used for analysis. 2 patients with Gel-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 | scores on a scale | Baseline and Week 13 |
|
|
|
|
| Secondary | Change 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | ITT population was used for analysis. 2 patients with Gel-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 | scores on a scale | Baseline and Week 13 |
|
|
|
|
| Secondary | Change From Baseline in Physician Global Evaluations | Observed physician global 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. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo. | ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 13 |
|
|
|
|
| Secondary | Acetaminophen Consumption | Weekly mean acetaminophen consumption between weeks 9 and 13. | ITT population was used for analysis. 2 patients with Gel-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 | Weeks 9 to 13 (5 weeks) |
|
|
|
|
| 8 |
| 249 |
| 122 |
| 249 |
| EG001 | PBS Placebo | Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint. | 0 | 128 | 55 | 128 |
| Vision blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Femoral hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cryptogenic cirrhosis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Transient Ischemic attack | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Exertional Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arthralgia | 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, information, results or similar information without the express of permission of SKK.
| D012216 |
| Rheumatic Diseases |
| 0.242 |
P-value for OMERACT-OARSI response. |
| Odds Ratio (OR) |
| 1.27 |
| 95 |
| No |
| Superiority or Other |