Pain
Conditions
Keywords
Pain, abdominoplasty, PCA
Brief summary
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain following abdominoplasty.
Detailed description
The primary objective is to evaluate the analgesic efficacy of intravenous (IV) TRV130 administered via patient controlled analgesia device (PCA) compared with placebo administered via PCA in patients with moderate to severe, acute postoperative pain following abdominoplasty.
Interventions
DRUGTRV130
Rescue: Ibuprofen, oxycodone
DRUGMorphine
Rescue: Ibuprofen, oxycodone
DRUGPlacebo
Rescue: Ibuprofen, oxycodone
Sponsors
Lotus Clinical Research, LLC
Trevena Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* \>=18 and \<=65 years of age. * Plans to undergo an abdominoplasty procedure with no additional collateral procedures. * Is able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure.
Exclusion criteria
* ASA Physical Status Classification System classification of P3 or worse. * Has surgical or post-surgical complications. * Has clinically significant medical conditions or history of such conditions that 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. * Has previously participated in another TRV130 clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo | 24-hours | Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine | 24-hours | Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Protocol v1-4 TRV130 0.1 mg TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout. | 39 |
| Protocol v1-4 Morphine Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout. | 42 |
| Protocol v1-4 Placebo Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout. | 19 |
| Protocol v5 TRV130 0.35 mg TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout. | 39 |
| Protocol v5 Morphine Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout. | 41 |
| Protocol v5 Placebo Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout. | 20 |
| Total | 200 |
Baseline characteristics
| Characteristic | Protocol v1-4 Morphine | Protocol v1-4 Placebo | Protocol v5 TRV130 0.35 mg | Protocol v5 Morphine | Protocol v5 Placebo | Protocol v1-4 TRV130 0.1 mg | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 19 Participants | 39 Participants | 41 Participants | 20 Participants | 39 Participants | 200 Participants |
| Age, Continuous | 37.0 years STANDARD_DEVIATION 9.23 | 36.6 years STANDARD_DEVIATION 8.6 | 40.3 years STANDARD_DEVIATION 11.987 | 38.4 years STANDARD_DEVIATION 9.064 | 38.5 years STANDARD_DEVIATION 10.018 | 37.8 years STANDARD_DEVIATION 8.07 | 38.2 years STANDARD_DEVIATION 9.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 5 Participants | 16 Participants | 16 Participants | 5 Participants | 15 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 14 Participants | 23 Participants | 25 Participants | 15 Participants | 24 Participants | 129 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 10 Participants | 18 Participants | 17 Participants | 10 Participants | 12 Participants | 82 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 24 Participants | 8 Participants | 18 Participants | 21 Participants | 9 Participants | 27 Participants | 107 Participants |
| Region of Enrollment United States | 42 participants | 19 participants | 39 participants | 41 participants | 20 participants | 39 participants | 200 participants |
| Sex: Female, Male Female | 42 Participants | 19 Participants | 39 Participants | 41 Participants | 18 Participants | 39 Participants | 198 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 42 | 0 / 19 | 0 / 39 | 0 / 41 | 0 / 20 |
| other Total, other adverse events | 26 / 39 | 39 / 42 | 8 / 19 | 32 / 39 | 39 / 41 | 16 / 20 |
| serious Total, serious adverse events | 0 / 39 | 0 / 42 | 0 / 19 | 0 / 39 | 1 / 41 | 0 / 20 |
Outcome results
Primary
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.
Time frame: 24-hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protocol v1-4 TRV130 0.1 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo | -3.8 score on a scale | Standard Deviation 2.53 |
| Protocol v1-4 Placebo | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo | -1.7 score on a scale | Standard Deviation 2.26 |
| Protocol v5 TRV130 0.35 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo | -3.5 score on a scale | Standard Deviation 2.32 |
| Protocol v5 Placebo | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo | -1.2 score on a scale | Standard Deviation 2.93 |
Secondary
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.
Time frame: 24-hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protocol v1-4 TRV130 0.1 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine | -3.8 score on a scale | Standard Deviation 2.53 |
| Protocol v1-4 Placebo | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine | -3.4 score on a scale | Standard Deviation 2.74 |
| Protocol v5 TRV130 0.35 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine | -3.5 score on a scale | Standard Deviation 2.32 |
| Protocol v5 Placebo | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine | -3.6 score on a scale | Standard Deviation 2.61 |