Trial Outcomes & Findings for A Study of TRV130 for the Treatment of Pain After Bunionectomy (NCT NCT02100748)
NCT ID: NCT02100748
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 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
333 participants
Primary outcome timeframe
48 hours
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Part A - TRV130 1 mg
TRV130 1 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 2 mg
TRV130 2 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 3 mg
TRV130 3 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 4 mg
TRV130 4 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - Morphine
Morphine 4 mg IV Q4H x 48 h
Morphine: Morphine 4 mg will be administered every 4 hours
|
Part A - Placebo
Placebo (D5W) IV Q4H x 48 h
Placebo: Placebo will be administered every 4 hours
|
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
|
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
|
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
|
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
|
Part B - Placebo
Placebo (D5W) IV Q3H x 48 h
Placebo: Placebo will be administered every 3 hours
|
Part B - Morphine
Morphine 4 mg IV Q4H x 48 h
Morphine: Morphine 4 mg will be administered every 4 hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
22
|
22
|
25
|
23
|
20
|
38
|
36
|
31
|
28
|
39
|
|
Overall Study
COMPLETED
|
23
|
23
|
21
|
21
|
23
|
23
|
18
|
34
|
33
|
29
|
26
|
39
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
1
|
2
|
0
|
2
|
4
|
3
|
2
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of TRV130 for the Treatment of Pain After Bunionectomy
Baseline characteristics by cohort
| Measure |
Part A - TRV130 1 mg
n=25 Participants
TRV130 1 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 2 mg
n=24 Participants
TRV130 2 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 3 mg
n=22 Participants
TRV130 3 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 4 mg
n=22 Participants
TRV130 4 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - Morphine
n=25 Participants
Morphine 4 mg IV Q4H x 48 h
Morphine: Morphine 4 mg will be administered every 4 hours
|
Part A - Placebo
n=23 Participants
Placebo (D5W) IV Q4H x 48 h
Placebo: Placebo will be administered every 4 hours
|
Part B - TRV130 0.5 mg
n=20 Participants
TRV130 0.5 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - TRV130 1 mg
n=38 Participants
TRV130 1 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - TRV130 2 mg
n=36 Participants
TRV130 2 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - TRV130 3 mg
n=31 Participants
TRV130 3 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - Placebo
n=28 Participants
Placebo (D5W) IV Q3H x 48 h
Placebo: Placebo will be administered every 3 hours
|
Part B - Morphine
n=39 Participants
Morphine 4 mg IV Q4H x 48 h
Morphine: Morphine 4 mg will be administered every 4 hours
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 12.52 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 12.06 • n=7 Participants
|
40.3 years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 13.66 • n=4 Participants
|
41.5 years
STANDARD_DEVIATION 12.53 • n=21 Participants
|
43.5 years
STANDARD_DEVIATION 9.94 • n=10 Participants
|
38.6 years
STANDARD_DEVIATION 11.38 • n=115 Participants
|
43.3 years
STANDARD_DEVIATION 11.02 • n=6 Participants
|
36.7 years
STANDARD_DEVIATION 12.23 • n=6 Participants
|
37.5 years
STANDARD_DEVIATION 10.58 • n=64 Participants
|
39.9 years
STANDARD_DEVIATION 11.04 • n=17 Participants
|
42.6 years
STANDARD_DEVIATION 13.09 • n=21 Participants
|
41.2 years
STANDARD_DEVIATION 12.11 • n=22 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
34 Participants
n=6 Participants
|
32 Participants
n=6 Participants
|
29 Participants
n=64 Participants
|
25 Participants
n=17 Participants
|
31 Participants
n=21 Participants
|
297 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
8 Participants
n=21 Participants
|
36 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
28 Participants
n=6 Participants
|
24 Participants
n=6 Participants
|
24 Participants
n=64 Participants
|
22 Participants
n=17 Participants
|
27 Participants
n=21 Participants
|
261 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
5 Participants
n=17 Participants
|
11 Participants
n=21 Participants
|
58 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
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
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Asian
|
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
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Other - Race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
11 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
9 Participants
n=21 Participants
|
88 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
30 Participants
n=6 Participants
|
28 Participants
n=6 Participants
|
20 Participants
n=64 Participants
|
22 Participants
n=17 Participants
|
30 Participants
n=21 Participants
|
245 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
22 participants
n=5 Participants
|
22 participants
n=4 Participants
|
25 participants
n=21 Participants
|
23 participants
n=10 Participants
|
20 participants
n=115 Participants
|
38 participants
n=6 Participants
|
36 participants
n=6 Participants
|
31 participants
n=64 Participants
|
28 participants
n=17 Participants
|
39 participants
n=21 Participants
|
333 participants
n=22 Participants
|
PRIMARY outcome
Timeframe: 48 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 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.
Outcome measures
| Measure |
Part A - TRV130 1 mg
n=25 Participants
TRV130 1 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 2 mg
n=24 Participants
TRV130 2 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 3 mg
n=22 Participants
TRV130 3 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 4 mg
n=22 Participants
TRV130 4 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - Morphine
n=25 Participants
Morphine 4 mg IV Q4H x 48 h
Morphine: Morphine 4 mg will be administered every 4 hours
|
Part A - Placebo
n=23 Participants
Placebo (D5W) IV Q4H x 48 h
Placebo: Placebo will be administered every 4 hours
|
Part B - TRV130 0.5 mg
n=20 Participants
TRV130 0.5 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - TRV130 1 mg
n=38 Participants
TRV130 1 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - TRV130 2 mg
n=36 Participants
TRV130 2 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - TRV130 3 mg
n=31 Participants
TRV130 3 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - Placebo
n=28 Participants
Placebo (D5W) IV Q3H x 48 h
Placebo: Placebo will be administered every 3 hours
|
Part B - Morphine
n=39 Participants
Morphine 4 mg IV Q4H x 48 h
Morphine: Morphine 4 mg will be administered every 4 hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
-3.1 score on a scale
Standard Deviation 2.25
|
-2.6 score on a scale
Standard Deviation 1.82
|
-3.3 score on a scale
Standard Deviation 1.51
|
-4.1 score on a scale
Standard Deviation 2.02
|
-3.2 score on a scale
Standard Deviation 1.79
|
-3.0 score on a scale
Standard Deviation 2.36
|
-2.9 score on a scale
Standard Deviation 2.64
|
-3.7 score on a scale
Standard Deviation 2.10
|
-5.0 score on a scale
Standard Deviation 2.14
|
-2.8 score on a scale
Standard Deviation 2.12
|
-4.0 score on a scale
Standard Deviation 1.89
|
Adverse Events
Part A - TRV130 1 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Part A - TRV130 2 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Part A - TRV130 3 mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Part A - TRV130 4 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Part A - Morphine
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Part A - Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part B - TRV130 0.5 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Part B - TRV130 1 mg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Part B - TRV130 2 mg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Part B - TRV130 3 mg
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Part B - Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Part B - Morphine
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A - TRV130 1 mg
n=25 participants at risk
TRV130 1 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 2 mg
n=24 participants at risk
TRV130 2 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 3 mg
n=22 participants at risk
TRV130 3 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - TRV130 4 mg
n=22 participants at risk
TRV130 4 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
|
Part A - Morphine
n=25 participants at risk
Morphine 4 mg IV Q4H x 48 h
Morphine: Morphine 4 mg will be administered every 4 hours
|
Part A - Placebo
n=23 participants at risk
Placebo (D5W) IV Q4H x 48 h
Placebo: Placebo will be administered every 4 hours
|
Part B - TRV130 0.5 mg
n=20 participants at risk
TRV130 0.5 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - TRV130 1 mg
n=38 participants at risk
TRV130 1 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - TRV130 2 mg
n=36 participants at risk
TRV130 2 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - TRV130 3 mg
n=31 participants at risk
TRV130 3 mg IV Q3H x 48 h
TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours
|
Part B - Placebo
n=28 participants at risk
Placebo (D5W) IV Q3H x 48 h
Placebo: Placebo will be administered every 3 hours
|
Part B - Morphine
n=39 participants at risk
Morphine 4 mg IV Q4H x 48 h
Morphine: Morphine 4 mg will be administered every 4 hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
36.0%
9/25
|
58.3%
14/24
|
50.0%
11/22
|
72.7%
16/22
|
64.0%
16/25
|
13.0%
3/23
|
35.0%
7/20
|
34.2%
13/38
|
55.6%
20/36
|
74.2%
23/31
|
25.0%
7/28
|
56.4%
22/39
|
|
Nervous system disorders
Dizziness
|
36.0%
9/25
|
54.2%
13/24
|
59.1%
13/22
|
77.3%
17/22
|
44.0%
11/25
|
8.7%
2/23
|
20.0%
4/20
|
57.9%
22/38
|
47.2%
17/36
|
58.1%
18/31
|
14.3%
4/28
|
43.6%
17/39
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25
|
20.8%
5/24
|
31.8%
7/22
|
50.0%
11/22
|
44.0%
11/25
|
4.3%
1/23
|
0.00%
0/20
|
10.5%
4/38
|
27.8%
10/36
|
54.8%
17/31
|
0.00%
0/28
|
30.8%
12/39
|
|
Nervous system disorders
Headache
|
20.0%
5/25
|
25.0%
6/24
|
18.2%
4/22
|
22.7%
5/22
|
28.0%
7/25
|
13.0%
3/23
|
25.0%
5/20
|
26.3%
10/38
|
19.4%
7/36
|
22.6%
7/31
|
17.9%
5/28
|
23.1%
9/39
|
|
Nervous system disorders
Somnolence
|
16.0%
4/25
|
8.3%
2/24
|
40.9%
9/22
|
18.2%
4/22
|
32.0%
8/25
|
4.3%
1/23
|
20.0%
4/20
|
13.2%
5/38
|
11.1%
4/36
|
12.9%
4/31
|
10.7%
3/28
|
17.9%
7/39
|
|
Gastrointestinal disorders
Constipation
|
12.0%
3/25
|
8.3%
2/24
|
9.1%
2/22
|
18.2%
4/22
|
16.0%
4/25
|
4.3%
1/23
|
10.0%
2/20
|
15.8%
6/38
|
8.3%
3/36
|
16.1%
5/31
|
3.6%
1/28
|
5.1%
2/39
|
|
Vascular disorders
Hot Flash
|
8.0%
2/25
|
12.5%
3/24
|
13.6%
3/22
|
27.3%
6/22
|
0.00%
0/25
|
0.00%
0/23
|
0.00%
0/20
|
5.3%
2/38
|
13.9%
5/36
|
12.9%
4/31
|
0.00%
0/28
|
10.3%
4/39
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25
|
4.2%
1/24
|
9.1%
2/22
|
13.6%
3/22
|
16.0%
4/25
|
4.3%
1/23
|
0.00%
0/20
|
2.6%
1/38
|
11.1%
4/36
|
9.7%
3/31
|
7.1%
2/28
|
5.1%
2/39
|
|
Gastrointestinal disorders
Dry Mouth
|
4.0%
1/25
|
12.5%
3/24
|
9.1%
2/22
|
4.5%
1/22
|
8.0%
2/25
|
0.00%
0/23
|
0.00%
0/20
|
5.3%
2/38
|
11.1%
4/36
|
3.2%
1/31
|
7.1%
2/28
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Hyperhydrosis
|
0.00%
0/25
|
12.5%
3/24
|
4.5%
1/22
|
18.2%
4/22
|
4.0%
1/25
|
0.00%
0/23
|
0.00%
0/20
|
0.00%
0/38
|
8.3%
3/36
|
16.1%
5/31
|
0.00%
0/28
|
2.6%
1/39
|
|
Vascular disorders
Flushing
|
4.0%
1/25
|
12.5%
3/24
|
4.5%
1/22
|
4.5%
1/22
|
0.00%
0/25
|
0.00%
0/23
|
0.00%
0/20
|
7.9%
3/38
|
16.7%
6/36
|
9.7%
3/31
|
0.00%
0/28
|
10.3%
4/39
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/25
|
12.5%
3/24
|
4.5%
1/22
|
9.1%
2/22
|
0.00%
0/25
|
0.00%
0/23
|
0.00%
0/20
|
5.3%
2/38
|
5.6%
2/36
|
0.00%
0/31
|
0.00%
0/28
|
5.1%
2/39
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/25
|
4.2%
1/24
|
13.6%
3/22
|
0.00%
0/22
|
4.0%
1/25
|
0.00%
0/23
|
5.0%
1/20
|
0.00%
0/38
|
5.6%
2/36
|
6.5%
2/31
|
3.6%
1/28
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
12.0%
3/25
|
0.00%
0/24
|
4.5%
1/22
|
0.00%
0/22
|
0.00%
0/25
|
0.00%
0/23
|
0.00%
0/20
|
0.00%
0/38
|
0.00%
0/36
|
3.2%
1/31
|
3.6%
1/28
|
2.6%
1/39
|
|
General disorders
Feeling Hot
|
0.00%
0/25
|
0.00%
0/24
|
9.1%
2/22
|
18.2%
4/22
|
4.0%
1/25
|
0.00%
0/23
|
0.00%
0/20
|
2.6%
1/38
|
0.00%
0/36
|
0.00%
0/31
|
0.00%
0/28
|
0.00%
0/39
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalized
|
0.00%
0/25
|
0.00%
0/24
|
4.5%
1/22
|
9.1%
2/22
|
16.0%
4/25
|
0.00%
0/23
|
5.0%
1/20
|
2.6%
1/38
|
2.8%
1/36
|
3.2%
1/31
|
0.00%
0/28
|
5.1%
2/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER