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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an improvement in pain levels and range of motion.
To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUFLEXXA | Experimental | ACTIVE CONTROL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUFLEXXA | Drug | 2.5 mL of EUFLEXXA (per injection) x 3 injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Reduction in Pain by the Scores. | Greater than 50 percent reduction in pain scores from baseline. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnold J. Weil, M.D. | Georgia Institute for Clinical Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | EUFLEXXA | All subjects received three injections (one each, in weeks 0 [baseline], 1, and 2 of high molecular weight hyaluronate (2.5 mL each) using standard injection techniques in the anterior or posterior approach. Sub- jects were evaluated at screening and baseline, and at weeks 1, 2, 6, 14, 26, and 27 (last evaluation by telephone). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EUFLEXXA | ACTIVE CONTROL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With a Reduction in Pain by the Scores. | Greater than 50 percent reduction in pain scores from baseline. |  | Posted | Number | participants | 6 months |
|
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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 | EUFLEXXA | ACTIVE CONTROL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arnold Weil, MD | Georgia Institute for Clinical Research, LLC | 770-421-2030 | research@lowbackpain.com |
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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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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 32 |
| 0 |
| 32 |
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