Acute Pain
Conditions
Brief summary
The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.
Interventions
Sponsors
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 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. * Experiences a pain intensity rating of moderate to severe acute pain. * 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 |
|---|---|
| Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo. | 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Respiratory Safety Events Compared to Morphine. | 48 hours | — |
| Duration of Respiratory Safety Events Compared to Morphine. | 48 hours | — |
| Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine. | 48 hours | Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS assessment is captured in the primary outcome measure. |
| Number of Patients With Treatment-related Adverse Events. | 48 hours | — |
Countries
United States
Participant flow
Pre-assignment details
Pre-Surgical Entry Criteria
Participants by arm
| Arm | Count |
|---|---|
| Treatment 1 Oliceridine Oliceridine 0.1 mg | 76 |
| Treatment 2 Oliceridine Oliceridine 0.35 mg | 79 |
| Treatment 3 Oliceridine Oliceridine 0.5 mg | 79 |
| Placebo Placebo | 79 |
| Morphine Morphine | 76 |
| Total | 389 |
Baseline characteristics
| Characteristic | Treatment 1 Oliceridine | Treatment 2 Oliceridine | Treatment 3 Oliceridine | Placebo | Morphine | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 6 Participants | 4 Participants | 3 Participants | 6 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 73 Participants | 75 Participants | 76 Participants | 70 Participants | 363 Participants |
| Age, Continuous | 47.5 years STANDARD_DEVIATION 12.65 | 43.6 years STANDARD_DEVIATION 13.91 | 46.9 years STANDARD_DEVIATION 13.81 | 44.1 years STANDARD_DEVIATION 12.58 | 43.3 years STANDARD_DEVIATION 14.13 | 45.1 years STANDARD_DEVIATION 13.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 25 Participants | 19 Participants | 17 Participants | 18 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 54 Participants | 60 Participants | 62 Participants | 58 Participants | 293 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 0 participants | 2 participants | 0 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Asian | 4 participants | 4 participants | 1 participants | 1 participants | 4 participants | 14 participants |
| Race/Ethnicity, Customized Black or African American | 22 participants | 17 participants | 13 participants | 21 participants | 21 participants | 94 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 1 participants | 2 participants | 0 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 0 participants | 1 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized White | 47 participants | 56 participants | 61 participants | 56 participants | 50 participants | 270 participants |
| Region of Enrollment United States | 76 participants | 79 participants | 79 participants | 79 participants | 76 participants | 389 participants |
| Sex: Female, Male Female | 64 Participants | 65 Participants | 66 Participants | 70 Participants | 65 Participants | 330 Participants |
| Sex: Female, Male Male | 12 Participants | 14 Participants | 13 Participants | 9 Participants | 11 Participants | 59 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 79 | 0 / 79 | 0 / 79 | 0 / 76 |
| other Total, other adverse events | 56 / 76 | 68 / 79 | 72 / 79 | 54 / 79 | 73 / 76 |
| serious Total, serious adverse events | 0 / 76 | 0 / 79 | 0 / 79 | 0 / 79 | 0 / 76 |
Outcome results
Primary
Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.
Time frame: 48 hours
Population: The analysis population reflects the number of patients treated with study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment 1 Oliceridine | Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo. | 38 Participants |
| Treatment 2 Oliceridine | Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo. | 49 Participants |
| Treatment 3 Oliceridine | Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo. | 52 Participants |
| Placebo | Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo. | 12 Participants |
| Morphine | Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo. | 54 Participants |
Secondary
Duration of Respiratory Safety Events Compared to Morphine.
Time frame: 48 hours
Population: The analysis population reflects the number of patients treated with study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1 Oliceridine | Duration of Respiratory Safety Events Compared to Morphine. | 2.21 hours | Standard Error 1.796 |
| Treatment 2 Oliceridine | Duration of Respiratory Safety Events Compared to Morphine. | 3.44 hours | Standard Error 1.186 |
| Treatment 3 Oliceridine | Duration of Respiratory Safety Events Compared to Morphine. | 3.34 hours | Standard Error 0.797 |
| Placebo | Duration of Respiratory Safety Events Compared to Morphine. | 2.94 hours | Standard Error 1.074 |
| Morphine | Duration of Respiratory Safety Events Compared to Morphine. | 5.14 hours | Standard Error 1.06 |
Secondary
Number of Patients With Treatment-related Adverse Events.
Time frame: 48 hours
Population: The analysis population reflects the number of patients treated with study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment 1 Oliceridine | Number of Patients With Treatment-related Adverse Events. | 48 Participants |
| Treatment 2 Oliceridine | Number of Patients With Treatment-related Adverse Events. | 59 Participants |
| Treatment 3 Oliceridine | Number of Patients With Treatment-related Adverse Events. | 65 Participants |
| Placebo | Number of Patients With Treatment-related Adverse Events. | 32 Participants |
| Morphine | Number of Patients With Treatment-related Adverse Events. | 68 Participants |
Secondary
Number of Respiratory Safety Events Compared to Morphine.
Time frame: 48 hours
Population: The analysis population reflects the number of patients treated with study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1 Oliceridine | Number of Respiratory Safety Events Compared to Morphine. | 1 Respiratory Safety Events |
| Treatment 2 Oliceridine | Number of Respiratory Safety Events Compared to Morphine. | 7 Respiratory Safety Events |
| Treatment 3 Oliceridine | Number of Respiratory Safety Events Compared to Morphine. | 11 Respiratory Safety Events |
| Placebo | Number of Respiratory Safety Events Compared to Morphine. | 0 Respiratory Safety Events |
| Morphine | Number of Respiratory Safety Events Compared to Morphine. | 14 Respiratory Safety Events |
Secondary
Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine.
Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS assessment is captured in the primary outcome measure.
Time frame: 48 hours
Population: The analysis population reflects the number of patients treated with study medication. The morphine and placebo Arms/Groups are not included, as this is a comparison of study medication against morphine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1 Oliceridine | Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine. | 1.5 odds ratio |
| Treatment 2 Oliceridine | Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine. | 2.54 odds ratio |
| Treatment 3 Oliceridine | Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine. | 2.89 odds ratio |