Trial Outcomes & Findings for Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty (NCT NCT02820324)
NCT ID: NCT02820324
Last Updated: 2020-10-23
Results Overview
The NPRS is an 11-point scale from 0-10 where "0" = no pain and "10" = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
407 participants
Primary outcome timeframe
24 hours
Results posted on
2020-10-23
Participant Flow
Participant milestones
| Measure |
Treatment 1 Oliceridine
Oliceridine 0.1 mg
The loading dose was 1.5 mg with PCA demand doses of 0.1 mg. Supplemental doses of 0.75 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens.
|
Treatment 2 Oliceridine
Oliceridine 0.35 mg
The loading dose was 1.5 mg with PCA demand doses of 0.35 mg. Supplemental doses of 0.75 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens.
|
Treatment 3 Oliceridine
Oliceridine 0.5 mg
The loading dose was 1.5 mg with PCA demand doses of 0.5 mg. Supplemental doses of 0.75 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens.
|
Treatment 4 Placebo
Placebo
The loading dose was 1.5 mL with volume-matched PCA demand doses. Supplemental doses of 0.75 mL were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens.
|
Treatment 5 Morphine
Morphine
The loading dose for the morphine treatment regimen was 4 mg with 1 mg demand doses. Supplemental doses of 2 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
78
|
82
|
82
|
82
|
83
|
|
Overall Study
Treated With Study Medication
|
77
|
80
|
80
|
81
|
83
|
|
Overall Study
COMPLETED
|
76
|
79
|
79
|
79
|
80
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
Baseline characteristics by cohort
| Measure |
Treatment 1 Oliceridine
n=77 Participants
Oliceridine 0.1 mg
|
Treatment 2 Oliceridine
n=80 Participants
Oliceridine 0.35 mg
|
Treatment 3 Oliceridine
n=80 Participants
Oliceridine 0.5 mg
|
Treatment 4 Placebo
n=81 Participants
Placebo
|
Treatment 5 Morphine
n=83 Participants
Morphine
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
391 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 10.64 • n=5 Participants
|
42 years
STANDARD_DEVIATION 9.97 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 10.03 • n=5 Participants
|
42.2 years
STANDARD_DEVIATION 10.25 • n=4 Participants
|
40.4 years
STANDARD_DEVIATION 10.35 • n=21 Participants
|
41.4 years
STANDARD_DEVIATION 10.23 • n=10 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
398 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
132 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
269 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
125 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
257 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=5 Participants
|
80 participants
n=7 Participants
|
80 participants
n=5 Participants
|
81 participants
n=4 Participants
|
83 participants
n=21 Participants
|
401 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: The analysis population reflects the number of patients treated with study medication.
The NPRS is an 11-point scale from 0-10 where "0" = no pain and "10" = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit.
Outcome measures
| Measure |
Treatment 1 Oliceridine
n=77 Participants
Oliceridine 0.1 mg
|
Treatment 2 Oliceridine
n=80 Participants
Oliceridine 0.35 mg
|
Treatment 3 Oliceridine
n=80 Participants
Oliceridine 0.5 mg
|
Treatment 4 Placebo
n=81 Participants
Placebo
|
Treatment 5 Morphine
n=83 Participants
Morphine
|
|---|---|---|---|---|---|
|
Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.
|
47 Participants
|
61 Participants
|
56 Participants
|
37 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: The analysis population reflects the number of patients treated with study medication.
Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
Outcome measures
| Measure |
Treatment 1 Oliceridine
n=77 Participants
Oliceridine 0.1 mg
|
Treatment 2 Oliceridine
n=80 Participants
Oliceridine 0.35 mg
|
Treatment 3 Oliceridine
n=80 Participants
Oliceridine 0.5 mg
|
Treatment 4 Placebo
n=81 Participants
Placebo
|
Treatment 5 Morphine
n=83 Participants
Morphine
|
|---|---|---|---|---|---|
|
Number of Respiratory Safety Events Compared to Morphine.
|
6 Respiratory Safety Events
|
17 Respiratory Safety Events
|
18 Respiratory Safety Events
|
5 Respiratory Safety Events
|
22 Respiratory Safety Events
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: The analysis population reflects the number of patients treated with study medication.
Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
Outcome measures
| Measure |
Treatment 1 Oliceridine
n=77 Participants
Oliceridine 0.1 mg
|
Treatment 2 Oliceridine
n=80 Participants
Oliceridine 0.35 mg
|
Treatment 3 Oliceridine
n=80 Participants
Oliceridine 0.5 mg
|
Treatment 4 Placebo
n=81 Participants
Placebo
|
Treatment 5 Morphine
n=83 Participants
Morphine
|
|---|---|---|---|---|---|
|
Duration of Respiratory Events Compared to Morphine.
|
2.27 hours
Standard Error 0.924
|
2.97 hours
Standard Error 0.815
|
3.43 hours
Standard Error 1.049
|
4.12 hours
Standard Error 1.687
|
3.17 hours
Standard Error 0.869
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: 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.
Odds ratio of 24-hour responder analysis versus morphine. Number of patients who responded to study medication at the 24-hr NPRS assessment is captured in the primary outcome measure.
Outcome measures
| Measure |
Treatment 1 Oliceridine
n=77 Participants
Oliceridine 0.1 mg
|
Treatment 2 Oliceridine
n=80 Participants
Oliceridine 0.35 mg
|
Treatment 3 Oliceridine
n=80 Participants
Oliceridine 0.5 mg
|
Treatment 4 Placebo
Placebo
|
Treatment 5 Morphine
Morphine
|
|---|---|---|---|---|---|
|
Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine.
|
0.88 odds ratio
|
2.11 odds ratio
|
1.73 odds ratio
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Treatment 1 Oliceridine
n=77 Participants
Oliceridine 0.1 mg
|
Treatment 2 Oliceridine
n=80 Participants
Oliceridine 0.35 mg
|
Treatment 3 Oliceridine
n=80 Participants
Oliceridine 0.5 mg
|
Treatment 4 Placebo
n=81 Participants
Placebo
|
Treatment 5 Morphine
n=83 Participants
Morphine
|
|---|---|---|---|---|---|
|
Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine.
|
52 Participants
|
70 Participants
|
70 Participants
|
44 Participants
|
76 Participants
|
Adverse Events
Treatment 1 Oliceridine
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
Treatment 2 Oliceridine
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
Treatment 3 Oliceridine
Serious events: 3 serious events
Other events: 76 other events
Deaths: 0 deaths
Treatment 4 Placebo
Serious events: 0 serious events
Other events: 65 other events
Deaths: 0 deaths
Treatment 5 Morphine
Serious events: 1 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment 1 Oliceridine
n=77 participants at risk
Oliceridine 0.1 mg
|
Treatment 2 Oliceridine
n=80 participants at risk
Oliceridine 0.35 mg
|
Treatment 3 Oliceridine
n=80 participants at risk
Oliceridine 0.5 mg
|
Treatment 4 Placebo
n=81 participants at risk
Placebo
|
Treatment 5 Morphine
n=83 participants at risk
Morphine
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Wall Hematoma
|
0.00%
0/77
|
1.2%
1/80 • Number of events 1
|
0.00%
0/80
|
0.00%
0/81
|
0.00%
0/83
|
|
Injury, poisoning and procedural complications
Post Procedural Hemorrhage
|
0.00%
0/77
|
0.00%
0/80
|
1.2%
1/80 • Number of events 1
|
0.00%
0/81
|
0.00%
0/83
|
|
Nervous system disorders
Lethargy
|
0.00%
0/77
|
0.00%
0/80
|
1.2%
1/80 • Number of events 1
|
0.00%
0/81
|
0.00%
0/83
|
|
Nervous system disorders
Syncope
|
0.00%
0/77
|
0.00%
0/80
|
1.2%
1/80 • Number of events 1
|
0.00%
0/81
|
0.00%
0/83
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/80
|
0.00%
0/81
|
1.2%
1/83 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/80
|
0.00%
0/81
|
1.2%
1/83 • Number of events 1
|
Other adverse events
| Measure |
Treatment 1 Oliceridine
n=77 participants at risk
Oliceridine 0.1 mg
|
Treatment 2 Oliceridine
n=80 participants at risk
Oliceridine 0.35 mg
|
Treatment 3 Oliceridine
n=80 participants at risk
Oliceridine 0.5 mg
|
Treatment 4 Placebo
n=81 participants at risk
Placebo
|
Treatment 5 Morphine
n=83 participants at risk
Morphine
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
44.2%
34/77
|
61.3%
49/80
|
75.0%
60/80
|
46.9%
38/81
|
73.5%
61/83
|
|
Gastrointestinal disorders
Vomiting
|
23.4%
18/77
|
21.2%
17/80
|
42.5%
34/80
|
13.6%
11/81
|
53.0%
44/83
|
|
Nervous system disorders
Headache
|
15.6%
12/77
|
28.7%
23/80
|
26.2%
21/80
|
29.6%
24/81
|
28.9%
24/83
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.8%
6/77
|
20.0%
16/80
|
17.5%
14/80
|
4.9%
4/81
|
22.9%
19/83
|
|
Gastrointestinal disorders
Constipation
|
15.6%
12/77
|
16.2%
13/80
|
11.2%
9/80
|
7.4%
6/81
|
10.8%
9/83
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.0%
10/77
|
16.2%
13/80
|
11.2%
9/80
|
4.9%
4/81
|
18.1%
15/83
|
|
Nervous system disorders
Dizziness
|
14.3%
11/77
|
8.8%
7/80
|
8.8%
7/80
|
11.1%
9/81
|
15.7%
13/83
|
|
Nervous system disorders
Sedation
|
6.5%
5/77
|
13.8%
11/80
|
8.8%
7/80
|
8.6%
7/81
|
22.9%
19/83
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.9%
3/77
|
12.5%
10/80
|
11.2%
9/80
|
6.2%
5/81
|
8.4%
7/83
|
|
Vascular disorders
Hot Flash
|
2.6%
2/77
|
7.5%
6/80
|
6.2%
5/80
|
7.4%
6/81
|
7.2%
6/83
|
|
Psychiatric disorders
Anxiety
|
1.3%
1/77
|
5.0%
4/80
|
7.5%
6/80
|
2.5%
2/81
|
3.6%
3/83
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.9%
3/77
|
1.2%
1/80
|
7.5%
6/80
|
2.5%
2/81
|
0.00%
0/83
|
|
Psychiatric disorders
Restlessness
|
1.3%
1/77
|
6.2%
5/80
|
3.8%
3/80
|
3.7%
3/81
|
4.8%
4/83
|
|
Skin and subcutaneous tissue disorders
Hyperhydrosis
|
2.6%
2/77
|
5.0%
4/80
|
2.5%
2/80
|
2.5%
2/81
|
2.4%
2/83
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalized
|
1.3%
1/77
|
1.2%
1/80
|
7.5%
6/80
|
1.2%
1/81
|
8.4%
7/83
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
2/77
|
5.0%
4/80
|
1.2%
1/80
|
1.2%
1/81
|
0.00%
0/83
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.5%
5/77
|
1.2%
1/80
|
0.00%
0/80
|
3.7%
3/81
|
2.4%
2/83
|
|
Gastrointestinal disorders
Flatulence
|
5.2%
4/77
|
1.2%
1/80
|
1.2%
1/80
|
4.9%
4/81
|
2.4%
2/83
|
|
Nervous system disorders
Presyncope
|
5.2%
4/77
|
1.2%
1/80
|
1.2%
1/80
|
0.00%
0/81
|
2.4%
2/83
|
|
Nervous system disorders
Somnolence
|
2.6%
2/77
|
0.00%
0/80
|
5.0%
4/80
|
1.2%
1/81
|
7.2%
6/83
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER