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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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The purpose of this study is to determine the safety and efficacy of FX006 in bursal injections and to assess the patient's impression to change in their chronic pain, following treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FX006 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FX006 | Drug | Subjects will be injected with the 5mL of FX006. This injection may be followed with up to 3mL of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score | Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable). | Baseline,week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) Score | The PGIC is a 7 point scale ranging from very much improved (1) to very much worsened (7)
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pritish Bawa, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FX006 | Subjects will be injected with the 5mL of FX006. This injection may be followed with up to 3mL of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | FX006 | Subjects will be injected with the 5mL of FX006. This injection may be followed with up to 3mL of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score | Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable). | Data were not collected for two participants in the FX006 arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline,week 12 |
|
|
12 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 | FX006 | Subjects will be injected with the 5mL of FX006. This injection may be followed with up to 3mL of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
Adverse event relating to fall was not related to the treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pritish Bawa, MD | The University of Texas Health Science Center at Houston | 713-500-7702 | Pritish.Bawa@uth.tmc.edu |
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| 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 | Feb 12, 2021 | Oct 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000631825 | FX006 |
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| from start of treatment to week 12 of treatment |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Numeric Pain Rating Scale (NPRS) Score | Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable). | Median | Full Range | score on a scale |
|
| Baseline Patient Global Impression of Change (PGIC) score | The PGIC is a 7 point scale ranging from very much improved (1) to very much worsened (7) | Median | Full Range | score on a scale |
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) Score | The PGIC is a 7 point scale ranging from very much improved (1) to very much worsened (7)
| Data were not collected for two participants in the FX006 arm. | Posted | Median | Full Range | score on a scale | from start of treatment to week 12 of treatment |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 6 |
| 22 |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Fall | Nervous system disorders | MedDRA | Systematic Assessment |
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| Pain at Injection Site | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Subcutaneous and Skin Disorders-other-lump at injection site | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
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