Acute Pain
Conditions
Keywords
moderate to severe acute pain, bunionectomy
Brief summary
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.
Detailed description
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.
Interventions
DRUGTRV130
TRV130 1 - 4 mg will be administered every 4 hours
DRUGMorphine
Morphine 4 mg will be administered every 4 hours
DRUGPlacebo
Placebo will be administered every 4 hours
Sponsors
Trevena Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. * Experiences a pain intensity rating of ≥ 4 on an 11 point NRS * Able 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 48 Hours Between TRV130 and Placebo | 48 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 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A - TRV130 1 mg TRV130 1 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours | 25 |
| Part A - TRV130 2 mg TRV130 2 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours | 24 |
| Part A - TRV130 3 mg TRV130 3 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours | 22 |
| Part A - TRV130 4 mg TRV130 4 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours | 22 |
| Part A - Morphine Morphine 4 mg IV Q4H x 48 h
Morphine: Morphine 4 mg will be administered every 4 hours | 25 |
| Part A - Placebo Placebo (D5W) IV Q4H x 48 h
Placebo: Placebo will be administered every 4 hours | 23 |
| Part B - TRV130 0.5 mg TRV130 0.5 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours | 20 |
| Part B - TRV130 1 mg TRV130 1 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours | 38 |
| Part B - TRV130 2 mg TRV130 2 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours | 36 |
| Part B - TRV130 3 mg TRV130 3 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours | 31 |
| Part B - Placebo Placebo (D5W) IV Q3H x 48 h
Placebo: Placebo will be administered every 3 hours | 28 |
| Part B - Morphine Morphine 4 mg IV Q4H x 48 h
Morphine: Morphine 4 mg will be administered every 4 hours | 39 |
| Total | 333 |
Baseline characteristics
| Characteristic | Part B - Placebo | Part B - Morphine | Total | Part A - TRV130 3 mg | Part A - TRV130 4 mg | Part A - Morphine | Part A - Placebo | Part B - TRV130 0.5 mg | Part A - TRV130 1 mg | Part A - TRV130 2 mg | Part B - TRV130 1 mg | Part B - TRV130 2 mg | Part B - TRV130 3 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 11.04 | 42.6 years STANDARD_DEVIATION 13.09 | 41.2 years STANDARD_DEVIATION 12.11 | 40.3 years STANDARD_DEVIATION 13.33 | 42.1 years STANDARD_DEVIATION 13.66 | 41.5 years STANDARD_DEVIATION 12.53 | 43.5 years STANDARD_DEVIATION 9.94 | 38.6 years STANDARD_DEVIATION 11.38 | 47.1 years STANDARD_DEVIATION 12.52 | 41.8 years STANDARD_DEVIATION 12.06 | 43.3 years STANDARD_DEVIATION 11.02 | 36.7 years STANDARD_DEVIATION 12.23 | 37.5 years STANDARD_DEVIATION 10.58 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 5 Participants | 11 Participants | 58 Participants | 5 Participants | 0 Participants | 3 Participants | 6 Participants | 2 Participants | 3 Participants | 2 Participants | 6 Participants | 10 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 6 Participants | 9 Participants | 88 Participants | 3 Participants | 7 Participants | 10 Participants | 6 Participants | 3 Participants | 9 Participants | 8 Participants | 8 Participants | 8 Participants | 11 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 22 Participants | 30 Participants | 245 Participants | 19 Participants | 15 Participants | 15 Participants | 17 Participants | 17 Participants | 16 Participants | 16 Participants | 30 Participants | 28 Participants | 20 Participants |
| Race/Ethnicity, Customized Other - Race | 0 Participants | 0 Participants | 5 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 27 Participants | 261 Participants | 16 Participants | 21 Participants | 22 Participants | 17 Participants | 16 Participants | 22 Participants | 22 Participants | 28 Participants | 24 Participants | 24 Participants |
| Region of Enrollment United States | 28 participants | 39 participants | 333 participants | 22 participants | 22 participants | 25 participants | 23 participants | 20 participants | 25 participants | 24 participants | 38 participants | 36 participants | 31 participants |
| Sex: Female, Male Female | 25 Participants | 31 Participants | 297 Participants | 19 Participants | 20 Participants | 24 Participants | 21 Participants | 18 Participants | 22 Participants | 22 Participants | 34 Participants | 32 Participants | 29 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 36 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 4 Participants | 4 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 | 0 / 22 | 0 / 22 | 0 / 25 | 0 / 23 | 0 / 20 | 0 / 38 | 0 / 36 | 0 / 31 | 0 / 28 | 0 / 39 |
| other Total, other adverse events | 22 / 25 | 21 / 24 | 20 / 22 | 22 / 22 | 23 / 25 | 11 / 23 | 16 / 20 | 31 / 38 | 31 / 36 | 28 / 31 | 20 / 28 | 31 / 39 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 | 0 / 22 | 0 / 22 | 0 / 25 | 0 / 23 | 0 / 20 | 0 / 38 | 0 / 36 | 0 / 31 | 0 / 28 | 0 / 39 |
Outcome results
Primary
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 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 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A - TRV130 1 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -3.1 score on a scale | Standard Deviation 2.11 |
| Part A - TRV130 2 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -3.1 score on a scale | Standard Deviation 2.25 |
| Part A - TRV130 3 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -2.6 score on a scale | Standard Deviation 1.82 |
| Part A - TRV130 4 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -3.3 score on a scale | Standard Deviation 1.51 |
| Part A - Morphine | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -4.1 score on a scale | Standard Deviation 2.02 |
| Part A - Placebo | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -3.2 score on a scale | Standard Deviation 1.79 |
| Part B - TRV130 0.5 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -3.0 score on a scale | Standard Deviation 2.36 |
| Part B - TRV130 1 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -2.9 score on a scale | Standard Deviation 2.64 |
| Part B - TRV130 2 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -3.7 score on a scale | Standard Deviation 2.1 |
| Part B - TRV130 3 mg | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -5.0 score on a scale | Standard Deviation 2.14 |
| Part B - Placebo | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -2.8 score on a scale | Standard Deviation 2.12 |
| Part B - Morphine | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | -4.0 score on a scale | Standard Deviation 1.89 |