Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chiltern International Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SI-613 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SI-613 | Combination Product | SI-613 will be repeated intra-articularly administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks | Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model. | Baseline over 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26 | Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model. | Baseline, Weeks 12 and 26 |
| Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | United States | ||
| MM Medical Center, Inc. |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SI-613 | The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections). |
| FG001 | Placebo | The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SI-613 | The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections). |
| BG001 | Placebo | The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 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 | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks | Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline over 12 weeks |
|
Baseline up to Week 26
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SI-613 | The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site joint pain | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Dept. | Seikagaku Corporation | (81)3-5220-8948 | taku.hosaka@seikagaku.co.jp |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2017 | Aug 15, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656259 | diclofenac etalhyaluronate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Combination Product |
Placebo will be repeated intra-articularly administered. |
|
Observed VAS of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model. |
| Baseline, Weeks 12 and 26 |
| Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26 | Observed VAS of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model. | Baseline, Weeks 12 and 26 |
| Change From Baseline in WOMAC Total Score at Weeks 12 and 26 | WOMAC total score was the mean of WOMAC pain, physical function and stiffness subscores and ranges from 0 to 100 mm, where higher scores indicated worse response. Changes in WOMAC total score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model. | Baseline, Weeks 12 and 26 |
| Miami |
| Florida |
| 33185 |
| United States |
| Quality Research and Medical Center, LLC | Miami | Florida | 33186 | United States |
| Heartland Research Associates, LLC | Newton | Kansas | 67114 | United States |
| Central Kentucky Research Associates | Lexington | Kentucky | 40509 | United States |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Upstate Clinical Research Associates, LLC | Williamsville | New York | 14221 | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Withdrawal by Subject |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kilograms / meter square |
|
|
|
|
| Secondary | Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26 | Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Weeks 12 and 26 |
|
|
|
|
| Secondary | Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26 | Observed VAS of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Weeks 12 and 26 |
|
|
|
|
| Secondary | Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26 | Observed VAS of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Weeks 12 and 26 |
|
|
|
|
| Secondary | Change From Baseline in WOMAC Total Score at Weeks 12 and 26 | WOMAC total score was the mean of WOMAC pain, physical function and stiffness subscores and ranges from 0 to 100 mm, where higher scores indicated worse response. Changes in WOMAC total score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Weeks 12 and 26 |
|
|
|
|
| 0 |
| 39 |
| 1 |
| 39 |
| 7 |
| 39 |
| EG001 | Placebo | The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections). | 0 | 41 | 1 | 41 | 3 | 41 |
| Heat exhaustion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
| 0.5873 |
| Least Squares Mean Difference |
| -3.3 |
| 2-Sided |
| 95 |
| -15.2 |
| 8.6 |
| Superiority |
| 0.7806 |
| Least Squares Mean Difference |
| -1.8 |
| 2-Sided |
| 95 |
| -14.3 |
| 10.8 |
| Superiority |
| 0.3796 |
| Least Squares Mean Difference |
| -5.6 |
| 2-Sided |
| 95 |
| -18.3 |
| 7.1 |
| Superiority |
| 0.6901 |
| Least Squares Mean Difference |
| -2.5 |
| 2-Sided |
| 95 |
| -14.8 |
| 9.8 |
| Superiority |