Trial Outcomes & Findings for A Study of TRV130 for the Treatment of Pain After Abdominoplasty (NCT NCT02335294)
NCT ID: NCT02335294
Last Updated: 2020-09-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
24-hours
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Protocol v1-4 TRV130 0.1 mg
TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.
|
Protocol v1-4 Morphine
Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
|
Protocol v1-4 Placebo
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
Protocol v5 TRV130 0.35 mg
TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.
|
Protocol v5 Morphine
Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
|
Protocol v5 Placebo
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
42
|
19
|
39
|
41
|
20
|
|
Overall Study
COMPLETED
|
36
|
38
|
18
|
36
|
39
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
1
|
3
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of TRV130 for the Treatment of Pain After Abdominoplasty
Baseline characteristics by cohort
| Measure |
Protocol v1-4 TRV130 0.1 mg
n=39 Participants
TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.
|
Protocol v1-4 Morphine
n=42 Participants
Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
|
Protocol v1-4 Placebo
n=19 Participants
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
Protocol v5 TRV130 0.35 mg
n=39 Participants
TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.
|
Protocol v5 Morphine
n=41 Participants
Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
|
Protocol v5 Placebo
n=20 Participants
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
Total
n=200 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
200 Participants
n=8 Participants
|
|
Age, Categorical
>=65 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 8.07 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 9.23 • n=7 Participants
|
36.6 years
STANDARD_DEVIATION 8.60 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 11.987 • n=4 Participants
|
38.4 years
STANDARD_DEVIATION 9.064 • n=21 Participants
|
38.5 years
STANDARD_DEVIATION 10.018 • n=8 Participants
|
38.2 years
STANDARD_DEVIATION 9.57 • n=8 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
198 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
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
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
71 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
129 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
82 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
107 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (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
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
42 participants
n=7 Participants
|
19 participants
n=5 Participants
|
39 participants
n=4 Participants
|
41 participants
n=21 Participants
|
20 participants
n=8 Participants
|
200 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 24-hoursPain 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.
Outcome measures
| Measure |
Protocol v1-4 TRV130 0.1 mg
n=39 Participants
TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.
|
Protocol v1-4 Placebo
n=19 Participants
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
Protocol v5 TRV130 0.35 mg
n=39 Participants
TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.
|
Protocol v5 Placebo
n=20 Participants
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
|---|---|---|---|---|
|
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
|
-1.7 score on a scale
Standard Deviation 2.26
|
-3.5 score on a scale
Standard Deviation 2.32
|
-1.2 score on a scale
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: 24-hoursPain 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.
Outcome measures
| Measure |
Protocol v1-4 TRV130 0.1 mg
n=39 Participants
TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.
|
Protocol v1-4 Placebo
n=42 Participants
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
Protocol v5 TRV130 0.35 mg
n=39 Participants
TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.
|
Protocol v5 Placebo
n=41 Participants
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
|---|---|---|---|---|
|
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
|
-3.4 score on a scale
Standard Deviation 2.74
|
-3.5 score on a scale
Standard Deviation 2.32
|
-3.6 score on a scale
Standard Deviation 2.61
|
Adverse Events
Protocol v1-4 TRV130 0.1 mg
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Protocol v1-4 Morphine
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Protocol v1-4 Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Protocol v5 TRV130 0.35 mg
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Protocol v5 Morphine
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Protocol v5 Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Protocol v1-4 TRV130 0.1 mg
n=39 participants at risk
TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.
|
Protocol v1-4 Morphine
n=42 participants at risk
Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
|
Protocol v1-4 Placebo
n=19 participants at risk
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
Protocol v5 TRV130 0.35 mg
n=39 participants at risk
TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.
|
Protocol v5 Morphine
n=41 participants at risk
Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
|
Protocol v5 Placebo
n=20 participants at risk
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/19
|
0.00%
0/39
|
2.4%
1/41
|
0.00%
0/20
|
Other adverse events
| Measure |
Protocol v1-4 TRV130 0.1 mg
n=39 participants at risk
TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.
|
Protocol v1-4 Morphine
n=42 participants at risk
Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
|
Protocol v1-4 Placebo
n=19 participants at risk
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
Protocol v5 TRV130 0.35 mg
n=39 participants at risk
TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.
|
Protocol v5 Morphine
n=41 participants at risk
Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.
|
Protocol v5 Placebo
n=20 participants at risk
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
2.6%
1/39
|
4.8%
2/42
|
5.3%
1/19
|
0.00%
0/39
|
4.9%
2/41
|
5.0%
1/20
|
|
Gastrointestinal disorders
Nausea
|
41.0%
16/39
|
81.0%
34/42
|
15.8%
3/19
|
46.2%
18/39
|
63.4%
26/41
|
20.0%
4/20
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
6/39
|
40.5%
17/42
|
10.5%
2/19
|
15.4%
6/39
|
43.9%
18/41
|
5.0%
1/20
|
|
General disorders
Local Swelling
|
0.00%
0/39
|
2.4%
1/42
|
5.3%
1/19
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/20
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/39
|
0.00%
0/42
|
5.3%
1/19
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/39
|
0.00%
0/42
|
5.3%
1/19
|
2.6%
1/39
|
9.8%
4/41
|
5.0%
1/20
|
|
Nervous system disorders
Headache
|
15.4%
6/39
|
14.3%
6/42
|
0.00%
0/19
|
15.4%
6/39
|
19.5%
8/41
|
25.0%
5/20
|
|
Nervous system disorders
Presyncope
|
5.1%
2/39
|
2.4%
1/42
|
0.00%
0/19
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/20
|
|
Nervous system disorders
Sedation
|
2.6%
1/39
|
7.1%
3/42
|
0.00%
0/19
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/20
|
|
Nervous system disorders
Somnolence
|
0.00%
0/39
|
16.7%
7/42
|
0.00%
0/19
|
5.1%
2/39
|
7.3%
3/41
|
0.00%
0/20
|
|
Nervous system disorders
Tension Headache
|
2.6%
1/39
|
9.5%
4/42
|
10.5%
2/19
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
10.3%
4/39
|
26.2%
11/42
|
0.00%
0/19
|
30.8%
12/39
|
56.1%
23/41
|
20.0%
4/20
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/39
|
7.1%
3/42
|
0.00%
0/19
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
7.7%
3/39
|
21.4%
9/42
|
0.00%
0/19
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/39
|
2.4%
1/42
|
5.3%
1/19
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
1/39
|
7.1%
3/42
|
0.00%
0/19
|
2.6%
1/39
|
2.4%
1/41
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalized
|
0.00%
0/39
|
11.9%
5/42
|
0.00%
0/19
|
0.00%
0/39
|
2.4%
1/41
|
0.00%
0/20
|
|
Vascular disorders
Hypotension
|
15.4%
6/39
|
9.5%
4/42
|
5.3%
1/19
|
7.7%
3/39
|
7.3%
3/41
|
0.00%
0/20
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/19
|
0.00%
0/39
|
0.00%
0/41
|
5.0%
1/20
|
|
General disorders
Infusion Site Discomfort
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/19
|
5.1%
2/39
|
0.00%
0/41
|
0.00%
0/20
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/19
|
0.00%
0/39
|
4.9%
2/41
|
10.0%
2/20
|
|
General disorders
Infusion Site Inflammation
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/19
|
2.6%
1/39
|
0.00%
0/41
|
5.0%
1/20
|
|
General disorders
Infusion Site Pain
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/19
|
2.6%
1/39
|
0.00%
0/41
|
10.0%
2/20
|
|
Injury, poisoning and procedural complications
Postoperative Fever
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/19
|
0.00%
0/39
|
0.00%
0/41
|
5.0%
1/20
|
|
Investigations
Electrocardiogram T-Wave Abnormal
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/19
|
0.00%
0/39
|
4.9%
2/41
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/39
|
2.4%
1/42
|
0.00%
0/19
|
0.00%
0/39
|
0.00%
0/41
|
10.0%
2/20
|
|
Nervous system disorders
Syncope
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/19
|
0.00%
0/39
|
0.00%
0/41
|
5.0%
1/20
|
|
Psychiatric disorders
Insomina
|
0.00%
0/39
|
4.8%
2/42
|
0.00%
0/19
|
0.00%
0/39
|
0.00%
0/41
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/19
|
0.00%
0/39
|
0.00%
0/41
|
5.0%
1/20
|
|
Vascular disorders
Phlebitis
|
0.00%
0/39
|
0.00%
0/42
|
0.00%
0/19
|
5.1%
2/39
|
2.4%
1/41
|
20.0%
4/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER