Pain
Conditions
Keywords
Pain, Long bone, Fracture
Brief summary
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.
Detailed description
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.
Interventions
DRUGTRV130
Drug
Sponsors
Kestrel Biologic
Trevena Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years, inclusive * Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both) OR tibia, fibula (or both) BUT not fractures in more than 1 extremity * Able to understand and comply with study procedures and requirements, and provide written informed consent
Exclusion criteria
* Significant concomitant head, chest, or abdominal trauma * Multiple extremity trauma * Open fracture * Clinically significant medical condition or history of such condition that may place the patient at an unacceptable risk in the trial, may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication. | 3-hours | Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Average Change in NPRS | From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours | Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours |
| Time to First NPRS <= 3 | 3-hours | Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours |
| Safety Assessments | 3-hours | Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TRV130 Drug: TRV130 | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | TRV130 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 30 years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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
Time frame: 3-hours
Population: Study terminated early. Primary outcome not measured.
Secondary
Safety Assessments
Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments.
Time frame: 3-hours
Population: Study terminated early. Secondary outcome not measured.
Secondary
Time to First NPRS <= 3
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Time frame: 3-hours
Population: Study terminated early. Secondary outcome not measured.
Secondary
Time Weighted Average Change in NPRS
Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours
Time frame: From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours
Population: Study terminated early. Secondary outcome not measured.