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| Name | Class |
|---|---|
| Kestrel Biologic | INDUSTRY |
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The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe acute pain in patients presenting to the emergency department (ED) with a suspected/known, unilateral, closed long bone fracture.
This study is designed to evaluate the analgesic efficacy of TRV130 for the treatment of moderate to severe acute pain associated with a long bone fracture in patients presenting to the ED. The safety and tolerability of TRV130 will also be evaluated in this open-label pilot study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRV130 | Experimental | Drug: TRV130 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRV130 | Drug | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication. | Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours | 3-hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time Weighted Average Change in NPRS | Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours | From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours |
| Time to First NPRS <= 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Indiana University | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trevena, Inc. | Indianapolis | Indiana | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TRV130 | Drug: TRV130 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TRV130 | Drug: TRV130 |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication. | Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours | Study terminated early. Primary outcome not measured. | Posted | 3-hours |
|
|
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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 | TRV130 | Drug: TRV130 | 0 |
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Study terminated early due to lack of enrollment. Analyses for the primary and secondary outcomes were not completed. No mortalities, serious adverse events, or adverse events were reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Arscott | Trevena, Inc. | 6103548840 | karscott@trevena.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C586842 | ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine |
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Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
| 3-hours |
| Safety Assessments | Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments. | 3-hours |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| 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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| Secondary | Time Weighted Average Change in NPRS | Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours | Study terminated early. Secondary outcome not measured. | Posted | From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours |
|
|
| Secondary | Time to First NPRS <= 3 | Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours | Study terminated early. Secondary outcome not measured. | Posted | 3-hours |
|
|
| Secondary | Safety Assessments | Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments. | Study terminated early. Secondary outcome not measured. | Posted | 3-hours |
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| 0 |
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