Acute Pain
Conditions
Brief summary
Patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study. Patients will be treated with TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as determined by the investigator, for a duration not to exceed 14 days.
Detailed description
The duration of treatment for each patient will be determined by the clinical need for parenteral opioid therapy. Eligible patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study. Patients will be treated with TRV130 by IV bolus, PCA administration, or both, as determined by the investigator, for a duration not to exceed 14 days. The duration of treatment for each patient will be determined by the clinical need for parenteral opioid therapy. A follow-up assessment will take place 2-3 days after the completion of the treatment phase.
Interventions
DRUGTRV130
Sponsors
Trevena Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
include: * Moderate to severe acute pain for which parenteral opioid therapy is warranted * Able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure.
Exclusion criteria
include: * Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that would confound the interpretation of safety, tolerability, or efficacy data in the study. * Hemodynamic instability or respiratory insufficiency. * Advanced cancer in palliative or end-of-life care. * Another current painful condition (other than acute pain for which parenteral opioid therapy is warranted) that would confound the interpretation of safety, tolerability, or efficacy data in the study. * Clinically significant, immune-mediated hypersensitivity reaction to opioids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients That Experienced a Treatment-emergent Adverse Event | From first dose through 3 days after last dose, approximately 4 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TRV130 For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed.
For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval.
TRV130 | 768 |
| Total | 768 |
Baseline characteristics
| Characteristic | TRV130 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 247 Participants |
| Age, Categorical Between 18 and 65 years | 521 Participants |
| Age, Continuous | 54.1 years STANDARD_DEVIATION 16.08 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 5 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants |
| Race/Ethnicity, Customized Black or African American | 137 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 61 Participants |
| Race/Ethnicity, Customized Missing Ethnicity | 3 Participants |
| Race/Ethnicity, Customized Missing Race | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 704 Participants |
| Race/Ethnicity, Customized Other | 14 Participants |
| Race/Ethnicity, Customized White | 596 Participants |
| Region of Enrollment United States | 768 participants |
| Sex: Female, Male Female | 498 Participants |
| Sex: Female, Male Male | 270 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 768 |
| other Total, other adverse events | 403 / 768 |
| serious Total, serious adverse events | 26 / 768 |
Outcome results
Primary
Number of Patients That Experienced a Treatment-emergent Adverse Event
Time frame: From first dose through 3 days after last dose, approximately 4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TRV130 | Number of Patients That Experienced a Treatment-emergent Adverse Event | 490 Participants |