Trial Outcomes & Findings for Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain (NCT NCT02946073)
NCT ID: NCT02946073
Last Updated: 2021-10-15
Results Overview
Change from baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the primary timepoint will be Week 12 of the Double-Blind Phase based on the 11-Point numerical rating scale with 0 being no pain and 10 being the worst pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1053 participants
Primary outcome timeframe
12 weeks- from randomization baseline to 12 weeks after randomization
Results posted on
2021-10-15
Participant Flow
965 of those subjects entered the Double Blind phase of the study. 108 subjects signed consent as De Novo subjects, but 20 of those subjects were part of the Double Blind phase. The total number of subjects that signed consent was 1053 (965 + 88).Two sites had quality issues with the data, so those subjects were eliminated from the analysis. This made the total number of subjects who were analyzed 222 in the double blind randomized phase and 132 subjects for the open label phase.
Subjects are screened prior to entry into a titration phase where they are titrated to an appropriate dose. Once they are titrated, they were randomized and entered the double blind period or open label period for de novo subjects.
Participant milestones
| Measure |
CAM2038 q1w or q4w BPN Treatment- Double Blind Phase
CAM2038 50 mg/mL q1w at doses of 8 mg, 12 mg, 16 mg, 24 mg, or 32 mg. CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg. buprenorphine
|
Placebo Subcutaneous Injections-Double Blind Phase
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly
|
De Novo Subjects-Open Label Phase
De Novo subjects proceeded directly from the Open-Label Titration Period to the Open-Label Safety Extension Phase without participating in the Double-Blind Treatment Period. CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Rollover Subjects-Open Label
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
|---|---|---|---|---|
|
Titration Phase
STARTED
|
811
|
0
|
98
|
0
|
|
Titration Phase
COMPLETED
|
222
|
0
|
75
|
0
|
|
Titration Phase
NOT COMPLETED
|
589
|
0
|
23
|
0
|
|
Double Blind Phase
STARTED
|
112
|
110
|
0
|
0
|
|
Double Blind Phase
COMPLETED
|
88
|
70
|
0
|
0
|
|
Double Blind Phase
NOT COMPLETED
|
24
|
40
|
0
|
0
|
|
Open Label Phase
STARTED
|
0
|
0
|
75
|
57
|
|
Open Label Phase
COMPLETED
|
0
|
0
|
54
|
44
|
|
Open Label Phase
NOT COMPLETED
|
0
|
0
|
21
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double Blind Phase Only
Baseline characteristics by cohort
| Measure |
CAM2038 q1w or q4w BPN Treatment- Double Blind Phase
n=112 Participants
CAM2038 50 mg/mL q1w at doses of 8 mg, 12 mg, 16 mg, 24 mg, or 32 mg. CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg. buprenorphine
|
Placebo Subcutaneous Injections-Double Blind Phase
n=110 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
De Novo Subjects-Open Label
n=75 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Rollover Subjects-Open Label
n=57 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Total
n=354 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 12.19 • n=112 Participants • Double Blind Phase Only
|
54.7 years
STANDARD_DEVIATION 11.36 • n=110 Participants • Double Blind Phase Only
|
54.3 years
STANDARD_DEVIATION 10.27 • n=75 Participants • Open Label Phase Only
|
56.4 years
STANDARD_DEVIATION 11.49 • n=57 Participants • Open Label Phase Only
|
55.2 years
STANDARD_DEVIATION 10.82 • n=132 Participants • Open Label Phase Only
|
|
Sex: Female, Male
Female
|
66 Participants
n=112 Participants • Double Blind Phase only.
|
56 Participants
n=110 Participants • Double Blind Phase only.
|
44 Participants
n=75 Participants • Open Label Phase Only
|
34 Participants
n=57 Participants • Open Label Phase Only
|
78 Participants
n=132 Participants • Open Label Phase Only
|
|
Sex: Female, Male
Male
|
46 Participants
n=112 Participants • Double Blind Phase only.
|
54 Participants
n=110 Participants • Double Blind Phase only.
|
31 Participants
n=75 Participants • Open Label Phase Only
|
23 Participants
n=57 Participants • Open Label Phase Only
|
54 Participants
n=132 Participants • Open Label Phase Only
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=112 Participants • Double Blind Phase Only
|
11 Participants
n=110 Participants • Double Blind Phase Only
|
1 Participants
n=75 Participants • Open Phase Only
|
4 Participants
n=57 Participants • Open Phase Only
|
5 Participants
n=132 Participants • Open Phase Only
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=112 Participants • Double Blind Phase Only
|
97 Participants
n=110 Participants • Double Blind Phase Only
|
73 Participants
n=75 Participants • Open Phase Only
|
51 Participants
n=57 Participants • Open Phase Only
|
124 Participants
n=132 Participants • Open Phase Only
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=112 Participants • Double Blind Phase Only
|
2 Participants
n=110 Participants • Double Blind Phase Only
|
1 Participants
n=75 Participants • Open Phase Only
|
2 Participants
n=57 Participants • Open Phase Only
|
3 Participants
n=132 Participants • Open Phase Only
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=112 Participants • Double Blind Phase Only
|
0 Participants
n=110 Participants • Double Blind Phase Only
|
1 Participants
n=75 Participants • Open Label Phase Only
|
0 Participants
n=57 Participants • Open Label Phase Only
|
1 Participants
n=132 Participants • Open Label Phase Only
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=112 Participants • Double Blind Phase Only
|
1 Participants
n=110 Participants • Double Blind Phase Only
|
0 Participants
n=75 Participants • Open Label Phase Only
|
1 Participants
n=57 Participants • Open Label Phase Only
|
1 Participants
n=132 Participants • Open Label Phase Only
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=112 Participants • Double Blind Phase Only
|
0 Participants
n=110 Participants • Double Blind Phase Only
|
1 Participants
n=75 Participants • Open Label Phase Only
|
0 Participants
n=57 Participants • Open Label Phase Only
|
1 Participants
n=132 Participants • Open Label Phase Only
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=112 Participants • Double Blind Phase Only
|
12 Participants
n=110 Participants • Double Blind Phase Only
|
6 Participants
n=75 Participants • Open Label Phase Only
|
7 Participants
n=57 Participants • Open Label Phase Only
|
13 Participants
n=132 Participants • Open Label Phase Only
|
|
Race (NIH/OMB)
White
|
100 Participants
n=112 Participants • Double Blind Phase Only
|
97 Participants
n=110 Participants • Double Blind Phase Only
|
67 Participants
n=75 Participants • Open Label Phase Only
|
49 Participants
n=57 Participants • Open Label Phase Only
|
116 Participants
n=132 Participants • Open Label Phase Only
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=112 Participants • Double Blind Phase Only
|
0 Participants
n=110 Participants • Double Blind Phase Only
|
0 Participants
n=75 Participants • Open Label Phase Only
|
0 Participants
n=57 Participants • Open Label Phase Only
|
0 Participants
n=132 Participants • Open Label Phase Only
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=112 Participants • Double Blind Phase Only
|
0 Participants
n=110 Participants • Double Blind Phase Only
|
0 Participants
n=75 Participants • Open Label Phase Only
|
0 Participants
n=57 Participants • Open Label Phase Only
|
0 Participants
n=132 Participants • Open Label Phase Only
|
|
Body Mass Index
|
29.1 kg/m^2
STANDARD_DEVIATION 4.78 • n=112 Participants • Double Blind Phase Only
|
29.3 kg/m^2
STANDARD_DEVIATION 5.27 • n=110 Participants • Double Blind Phase Only
|
29.5 kg/m^2
STANDARD_DEVIATION 5.55 • n=75 Participants • Open Label Phase Only
|
29.1 kg/m^2
STANDARD_DEVIATION 5.29 • n=57 Participants • Open Label Phase Only
|
29.3 kg/m^2
STANDARD_DEVIATION 5.42 • n=132 Participants • Open Label Phase Only
|
|
Pain Score at Start of Open-Label Titration Period
|
7.0 units on a scale
STANDARD_DEVIATION 1.42 • n=112 Participants • Double Blind Phase Only
|
7.0 units on a scale
STANDARD_DEVIATION 1.39 • n=110 Participants • Double Blind Phase Only
|
6.7 units on a scale
STANDARD_DEVIATION 1.46 • n=75 Participants • Open Label Phase Only
|
6.6 units on a scale
STANDARD_DEVIATION 1.73 • n=57 Participants • Open Label Phase Only
|
6.7 units on a scale
STANDARD_DEVIATION 1.57 • n=132 Participants • Open Label Phase Only
|
PRIMARY outcome
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomizationPopulation: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Change from baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the primary timepoint will be Week 12 of the Double-Blind Phase based on the 11-Point numerical rating scale with 0 being no pain and 10 being the worst pain.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=112 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=110 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase.
Baseline
|
2.7 score on a scale
Standard Deviation 1.26
|
2.4 score on a scale
Standard Deviation 1.25
|
—
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase.
Change from Baseline to Week 12
|
-0.9 score on a scale
Standard Deviation 1.62
|
-1.9 score on a scale
Standard Deviation 1.97
|
—
|
PRIMARY outcome
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).Population: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Change from baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase based on the 11-Point numerical rating scale with 10 being the worst pain. Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=54 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=24 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
n=31 Participants
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 36
|
-0.920 score on a scale
Standard Deviation 1.48
|
-0.623 score on a scale
Standard Deviation 1.36
|
-1.119 score on a scale
Standard Deviation 1.42
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 28
|
-0.905 score on a scale
Standard Deviation 1.56
|
-0.338 score on a scale
Standard Deviation 1.06
|
-1.212 score on a scale
Standard Deviation 1.46
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 32
|
-0.941 score on a scale
Standard Deviation 1.64
|
-0.275 score on a scale
Standard Deviation 1.41
|
-1.111 score on a scale
Standard Deviation 1.27
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Baseline
|
2.839 score on a scale
Standard Deviation 1.0753
|
2.256 score on a scale
Standard Deviation 1.1642
|
1.944 score on a scale
Standard Deviation 1.1288
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 4
|
-0.434 score on a scale
Standard Deviation 0.94
|
-0.531 score on a scale
Standard Deviation 0.93
|
-1.586 score on a scale
Standard Deviation 1.80
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 8
|
-0.555 score on a scale
Standard Deviation 1.28
|
-0.729 score on a scale
Standard Deviation 0.99
|
-2.165 score on a scale
Standard Deviation 2.20
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 12
|
-0.752 score on a scale
Standard Deviation 1.35
|
-0.767 score on a scale
Standard Deviation 1.20
|
-2.079 score on a scale
Standard Deviation 2.01
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 16
|
-0.543 score on a scale
Standard Deviation 1.19
|
-0.312 score on a scale
Standard Deviation 0.68
|
-1.229 score on a scale
Standard Deviation 1.42
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 20
|
-0.690 score on a scale
Standard Deviation 1.47
|
-0.566 score on a scale
Standard Deviation 1.05
|
-1.013 score on a scale
Standard Deviation 1.63
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 24
|
-0.718 score on a scale
Standard Deviation 1.46
|
-0.872 score on a scale
Standard Deviation 1.51
|
-1.220 score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 40
|
-0.913 score on a scale
Standard Deviation 1.37
|
-0.519 score on a scale
Standard Deviation 1.51
|
-1.113 score on a scale
Standard Deviation 1.49
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 44
|
-0.767 score on a scale
Standard Deviation 1.32
|
-0.560 score on a scale
Standard Deviation 1.37
|
-1.282 score on a scale
Standard Deviation 1.57
|
|
Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase.
Change from Baseline to Week 48
|
-0.996 score on a scale
Standard Deviation 1.39
|
-0.619 score on a scale
Standard Deviation 1.58
|
-1.215 score on a scale
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomizationPopulation: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Change from baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) and the primary timepoint will be Week 12 of the Double-Blind Phase based on the 11-Point numerical rating scale with 0 being no pain and 10 being the worst pain.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=112 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=110 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Change From Baseline in the Weekly Average of (Daily) Worst Pain Intensity Scores at Week 12 of the Double-Blind Phase Based on 11-Point Numerical Rating Scale With 10 Being the Worst Pain.
Baseline
|
3.8 score on a scale
Standard Deviation 1.59
|
3.7 score on a scale
Standard Deviation 1.65
|
—
|
|
Change From Baseline in the Weekly Average of (Daily) Worst Pain Intensity Scores at Week 12 of the Double-Blind Phase Based on 11-Point Numerical Rating Scale With 10 Being the Worst Pain.
Change from Baseline to Week 12
|
-1.1 score on a scale
Standard Deviation 1.81
|
-2.2 score on a scale
Standard Deviation 2.18
|
—
|
SECONDARY outcome
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomizationPopulation: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Number of Responders With a 30% and 50% Reduction in WAAPI from the Open-Label Titration Period Baseline to Week 12 of the Double-Blind Treatment Period (mITT Population)
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=112 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=110 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Number of Subjects With a 30% and 50% Reduction in WAAPI From Baseline to Week 12 of the Double-Blind Phase.
>= 30% improvement
|
60 Participants
|
47 Participants
|
—
|
|
Number of Subjects With a 30% and 50% Reduction in WAAPI From Baseline to Week 12 of the Double-Blind Phase.
>= 50% improvement
|
44 Participants
|
32 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomizationPopulation: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Rescue medication usage (number of days used) during the Double-Blind Phase.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=112 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=110 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Summary of Rescue Medication Usage- Double-Blind Phase.
Baseline
|
3.4 Days
Standard Deviation 2.84
|
3.5 Days
Standard Deviation 2.91
|
—
|
|
Summary of Rescue Medication Usage- Double-Blind Phase.
Change from Baseline to Week 12
|
-1.5 Days
Standard Deviation 2.58
|
-2.1 Days
Standard Deviation 2.63
|
—
|
SECONDARY outcome
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomizationPopulation: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Change from Open Label Titration baseline to Week 12 of the Double-Blind Phase in EuroQol Group 5-dimension 5-level self-report questionnaire score. The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) descriptive system is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows subjects to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood, using a 5-level scale. These combinations of attributes were converted into a weighted health-state index score, according to the US population-based algorithm, with higher scores indicating better quality of life. The score ranges from 0-100 with 0 as the worst health and 100 as the best health.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=112 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=110 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Change From Open Label Titration Baseline to Week 12 of the Double-Blind Phase in EuroQol Group 5-dimension 5-level Self-report Questionnaire Score.
Titration Baseline
|
63.7 units on a scale
Standard Deviation 20.55
|
61.3 units on a scale
Standard Deviation 22.05
|
—
|
|
Change From Open Label Titration Baseline to Week 12 of the Double-Blind Phase in EuroQol Group 5-dimension 5-level Self-report Questionnaire Score.
Change from Baseline to Week 12
|
-9.4 units on a scale
Standard Deviation 18.47
|
-7.2 units on a scale
Standard Deviation 23.04
|
—
|
SECONDARY outcome
Timeframe: 23 weeks- from baseline to 12 weeks after randomizationPopulation: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Change from baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment score. The Work Productivity and Activity Impairment (WPAI) is a self-administered instrument used to measure the effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores (higher scores indicate greater impairment): Absenteeism (work time missed)，Presenteeism (impairment at work/reduced on-the-job effectiveness), Work Productivity Loss (overall work impairment/absenteeism plus presenteeism)，and Activity Impairment. Scores range from 0-100 for each of the four types with higher scores indicating greater impairment.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=112 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=110 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score
Baseline-Activity Impairment
|
58.8 score on a scale
Standard Deviation 23.68
|
61.2 score on a scale
Standard Deviation 22.74
|
—
|
|
Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score
Change from Baseline to Week 12 after randomization-Activity impairment
|
18.1 score on a scale
Standard Deviation 24.88
|
11.7 score on a scale
Standard Deviation 26.28
|
—
|
|
Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score
Baseline-Absenteesim
|
5.1 score on a scale
Standard Deviation 10.19
|
9.9 score on a scale
Standard Deviation 22.50
|
—
|
|
Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score
Change from Baseline to Week 12 after randomization-Absenteesim
|
-0.8 score on a scale
Standard Deviation 10.75
|
-4.6 score on a scale
Standard Deviation 22.88
|
—
|
|
Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score
Baseline-Presenteeism
|
38.9 score on a scale
Standard Deviation 22.33
|
47.8 score on a scale
Standard Deviation 25.20
|
—
|
|
Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score
Change from Baseline to Week 12 after randomization-Presenteeism
|
5.0 score on a scale
Standard Deviation 27.47
|
9.0 score on a scale
Standard Deviation 27.37
|
—
|
|
Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score
Baseline-Work Productivity Loss
|
41.3 score on a scale
Standard Deviation 23.09
|
52.3 score on a scale
Standard Deviation 26.77
|
—
|
|
Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score
Change from Baseline to Week 12 after randomization- Work Productivity Loss
|
5.4 score on a scale
Standard Deviation 23.05
|
7.8 score on a scale
Standard Deviation 26.40
|
—
|
SECONDARY outcome
Timeframe: 12 weeks- from randomization baseline to 12 weeks after randomizationPopulation: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Number of Subjects Discontinued due to loss of efficacy, defined as discontinuation of study drug for lack of efficacy.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=112 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=110 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Number of Subjects Discontinued Due to Loss of Efficacy
|
7 Participants
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeks- from baseline (randomization) to 12 weeks after randomizationPopulation: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Change from baseline to Week 12 of the Double-Blind Phase in Patient global Impression of Improvement (PGI-I) Scale. PGI-I)Scale is a single question 7-point likert scale that required the subject to assess how much his/her pain had improved or worsened relative to the start of the study at the beginning of the intervention . Ratings were: 1, much worse; 2, worse; 3, a little worse; 4, no change; 5, a little better; 6, better; or 7, much better
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=112 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=110 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Change From Baseline to Week 12 of the Double-Blind Phase in Patient Global Impression of Improvement (PGI-I) Scale
Baseline
|
6.0 units on a scale
Standard Deviation 0.96
|
6.2 units on a scale
Standard Deviation 0.74
|
—
|
|
Change From Baseline to Week 12 of the Double-Blind Phase in Patient Global Impression of Improvement (PGI-I) Scale
Change from Baseline to Week 12
|
0.4 units on a scale
Standard Deviation 1.48
|
1.5 units on a scale
Standard Deviation 1.63
|
—
|
SECONDARY outcome
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).Population: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Change from baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) and the primary timepoint will be Week 52 of the Open Label Phase based on the 11-Point numerical rating scale with 10 being the worst pain. Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=54 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=21 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
n=31 Participants
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 48
|
-1.059 score on a scale
Standard Deviation 1.59
|
-0.896 score on a scale
Standard Deviation 2.26
|
-1.292 score on a scale
Standard Deviation 1.78
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Baseline
|
4.139 score on a scale
Standard Deviation 1.55
|
3.717 score on a scale
Standard Deviation 3.86
|
3.246 score on a scale
Standard Deviation 3.29
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 4
|
-0.517 score on a scale
Standard Deviation 1.34
|
-0.859 score on a scale
Standard Deviation 1.57
|
-1.734 score on a scale
Standard Deviation 1.97
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 8
|
-0.625 score on a scale
Standard Deviation 1.48
|
-1.066 score on a scale
Standard Deviation 1.68
|
-2.404 score on a scale
Standard Deviation 2.47
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 12
|
-0.846 score on a scale
Standard Deviation 1.53
|
-1.157 score on a scale
Standard Deviation 1.95
|
-2.455 score on a scale
Standard Deviation 2.26
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 16
|
-0.689 score on a scale
Standard Deviation 1.51
|
-0.487 score on a scale
Standard Deviation 1.14
|
-1.587 score on a scale
Standard Deviation 2.03
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 20
|
-0.725 score on a scale
Standard Deviation 1.59
|
-0.592 score on a scale
Standard Deviation 1.157
|
-1.391 score on a scale
Standard Deviation 2.18
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 24
|
-0.735 score on a scale
Standard Deviation 1.67
|
-0.902 score on a scale
Standard Deviation 2.13
|
-1.461 score on a scale
Standard Deviation 1.97
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 28
|
-1.013 score on a scale
Standard Deviation 1.55
|
-0.518 score on a scale
Standard Deviation 1.74
|
-1.531 score on a scale
Standard Deviation 2.13
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 32
|
-0.996 score on a scale
Standard Deviation 1.90
|
-0.322 score on a scale
Standard Deviation 1.76
|
-1.462 score on a scale
Standard Deviation 2.06
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 36
|
-1.044 score on a scale
Standard Deviation 1.71
|
-0.682 score on a scale
Standard Deviation 0.20
|
-1.112 score on a scale
Standard Deviation 1.34
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 40
|
-0.935 score on a scale
Standard Deviation 1.50
|
-0.658 score on a scale
Standard Deviation 1.92
|
-1.087 score on a scale
Standard Deviation 1.48
|
|
Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase.
Change from Baseline to Week 44
|
-0.897 score on a scale
Standard Deviation 1.56
|
-0.764 score on a scale
Standard Deviation 2.03
|
-1.216 score on a scale
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).Population: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Subject Discontinued Due to Loss of Efficacy, Defined as Discontinuation of Study Drug for Lack of Efficacy Open Label Phase.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=54 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=24 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
n=31 Participants
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Subject Discontinued Due to Loss of Efficacy, Defined as Discontinuation of Study Drug for Lack of Efficacy.
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).Population: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Rescue medication usage (number of days used) during the Open Label Phase.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=54 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=24 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
n=31 Participants
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 32
|
-0.864 Days
Standard Deviation 2.36
|
-0.577 Days
Standard Deviation 2.12
|
-1.280 Days
Standard Deviation 2.70
|
|
Summary of Rescue Medication Usage-Open Label Phase
Baseline
|
1.172 Days
Standard Deviation 1.99
|
0.352 Days
Standard Deviation 0.68
|
1.330 Days
Standard Deviation 2.23
|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 4
|
-0.744 Days
Standard Deviation 1.54
|
-0.793 Days
Standard Deviation 2.47
|
-1.124 Days
Standard Deviation 2.32
|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 8
|
-0.301 Days
Standard Deviation 1.75
|
-0.671 Days
Standard Deviation 2.18
|
-1.672 Days
Standard Deviation 2.29
|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 12
|
-0.472 Days
Standard Deviation 1.99
|
-1.180 Days
Standard Deviation 2.48
|
-1.817 Days
Standard Deviation 2.53
|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 16
|
-0.679 Days
Standard Deviation 1.87
|
-0.418 Days
Standard Deviation 2.33
|
-0.990 Days
Standard Deviation 2.07
|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 20
|
-0.562 Days
Standard Deviation 2.00
|
-0.745 Days
Standard Deviation 2.02
|
-0.490 Days
Standard Deviation 2.48
|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 24
|
-0.689 Days
Standard Deviation 1.96
|
-0.959 Days
Standard Deviation 2.52
|
-0.933 Days
Standard Deviation 2.64
|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 28
|
-1.045 Days
Standard Deviation 2.17
|
-0.553 Days
Standard Deviation 1.64
|
-0.875 Days
Standard Deviation 2.80
|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 36
|
-0.989 Days
Standard Deviation 2.29
|
-0.359 Days
Standard Deviation 1.63
|
-1.479 Days
Standard Deviation 2.91
|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 40
|
-0.941 Days
Standard Deviation 2.41
|
-0.980 Days
Standard Deviation 2.26
|
-1.339 Days
Standard Deviation 2.81
|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 44
|
-1.050 Days
Standard Deviation 2.54
|
-0.767 Days
Standard Deviation 1.90
|
-1.465 Days
Standard Deviation 2.51
|
|
Summary of Rescue Medication Usage-Open Label Phase
Change from Baseline to Week 48
|
-1.088 Days
Standard Deviation 2.20
|
-0.929 Days
Standard Deviation 2.15
|
-2.302 Days
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).Population: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Change from Open Label Titration baseline in EuroQol Group 5-dimension 5-level self-report questionnaire score in the Open Label Phase. The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) descriptive system is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows subjects to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood, using a 5-level scale. These combinations of attributes were converted into a weighted health-state index score, according to the US population-based algorithm, with higher scores indicating better quality of life. The score ranges from 0-100 with 0 as the worst health and 100 as the best health.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=54 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=24 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
n=31 Participants
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Summary of Change From Baseline in EuroQoL Group EQ-5D-5L Scores Over Time-Open Label Phase
Baseline
|
76.59 score on a scale
Standard Deviation 13.31
|
83.38 score on a scale
Standard Deviation 14.89
|
79.65 score on a scale
Standard Deviation 14.00
|
|
Summary of Change From Baseline in EuroQoL Group EQ-5D-5L Scores Over Time-Open Label Phase
Change from Baseline at End of Treatment Visit
|
5.17 score on a scale
Standard Deviation 15.43
|
9.95 score on a scale
Standard Deviation 18.83
|
6.35 score on a scale
Standard Deviation 18.95
|
SECONDARY outcome
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).Population: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Summary of Change from Baseline in Clinical Global Impression of Improvement (CGI-I) scale. The Clinician Global Impression of Improvement (CGI-I) Scale is a 7-point scale that required the clinician to assess how much the subject's Pain had improved or worsened relative to the start of the study. Assessments were rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=54 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=24 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
n=31 Participants
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Summary of Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Scale-Open Label
Baseline
|
1.9 score on a scale
Standard Deviation 0.79
|
1.7 score on a scale
Standard Deviation 0.56
|
2.0 score on a scale
Standard Deviation 1.13
|
|
Summary of Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Scale-Open Label
Change from Baseline at End of Treatment Visit
|
-0.4 score on a scale
Standard Deviation 1.25
|
-0.1 score on a scale
Standard Deviation 1.08
|
0.1 score on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).Population: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Change from baseline in the Open Label Phase in Patient global Impression of Improvement (PGI-I) Scale. PGI-I Scale is a single question 7-point likert scale that required the subject to assess how much his/her pain had improved or worsened relative to the start of the study. Ratings were: 1, much worse; 2, worse; 3, a little worse; 4, no change; 5, a little better; 6, better; or 7, much better
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=54 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=24 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
n=31 Participants
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Summary of Change From Baseline in Patient Global Impression of Improvement (PGI-I) Scale
Baseline
|
5.8 score on a scale
Standard Deviation 0.84
|
6.1 score on a scale
Standard Deviation 1.10
|
6.3 score on a scale
Standard Deviation 0.84
|
|
Summary of Change From Baseline in Patient Global Impression of Improvement (PGI-I) Scale
Change from Baseline at End of Treatment Visit
|
0.2 score on a scale
Standard Deviation 1.16
|
-0.2 score on a scale
Standard Deviation 1.04
|
0.5 score on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).Population: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Change from baseline in the Open Label Phase in Work Productivity and Activity Impairment score with a range of 0-100 for 4 types of scores with higher scores indicating greater impairment. The Work Productivity and Activity Impairment (WPAI) is a self-administered instrument used to measure the effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores (higher scores indicate greater impairment): Absenteeism (work time missed)，Presenteeism (impairment at work/reduced on-the-job effectiveness), Work Productivity Loss (overall work impairment/absenteeism plus presenteeism)，and Activity Impairment. Scores range from 0-100 for each of the four types with higher scores indicating greater impairment.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=54 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=24 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
n=31 Participants
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Summary of Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Open Label Phase
Baseline-Absenteesim
|
1.538 score on a scale
Standard Deviation 5.55
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Summary of Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Open Label Phase
Change from Baseline at End of Treatment Visit-Absenteesim
|
0 score on a scale
Standard Deviation 0
|
-2.137 score on a scale
Standard Deviation 5.23
|
0 score on a scale
Standard Deviation 0
|
|
Summary of Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Open Label Phase
Baseline-Presenteeism
|
26.9 score on a scale
Standard Deviation 18.43
|
22.9 score on a scale
Standard Deviation 19.76
|
21.0 score on a scale
Standard Deviation 11.97
|
|
Summary of Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Open Label Phase
Change from Baseline at End of Treatment Visit-Presenteeism
|
1.0 score on a scale
Standard Deviation 15.95
|
1.7 score on a scale
Standard Deviation 7.53
|
6.7 score on a scale
Standard Deviation 23.98
|
|
Summary of Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Open Label Phase
Baseline-Work Productivity Loss
|
27.846 score on a scale
Standard Deviation 19.42
|
22.857 score on a scale
Standard Deviation 19.76
|
21.000 score on a scale
Standard Deviation 11.97
|
|
Summary of Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Open Label Phase
Change from Baseline at End of Treatment Visit- Work Productivity Loss
|
1.000 score on a scale
Standard Deviation 15.95
|
-0.043 score on a scale
Standard Deviation 11.05
|
6.667 score on a scale
Standard Deviation 23.98
|
|
Summary of Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Open Label Phase
Baseline-Activity Impairment
|
32.1 score on a scale
Standard Deviation 20.55
|
29.0 score on a scale
Standard Deviation 23.82
|
22.9 score on a scale
Standard Deviation 16.52
|
|
Summary of Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Open Label Phase
Change from Baseline at End of Treatment Visit-Activity Impairment
|
-12.1 score on a scale
Standard Deviation 22.20
|
-6.5 score on a scale
Standard Deviation 25.60
|
-18.2 score on a scale
Standard Deviation 22.45
|
SECONDARY outcome
Timeframe: 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects).Population: Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance
Number of Subjects Discontinued due to loss of efficacy, defined as discontinuation of study drug for lack of efficacy.
Outcome measures
| Measure |
CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w
n=54 Participants
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Placebo Subcutaneous Injections
n=24 Participants
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Rollover Placebo Injections
n=31 Participants
Placebo injections during Double Blind Phase, CAM2038 50 mg/mL q1w at doses of 4 mg, 8 mg, 12 mg orCAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg buprenorphine during Open Label Phase
|
|---|---|---|---|
|
Number of Subjects Discontinued Due to Loss of Efficacy
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
CAM2038 q1w or q4w BPN Treatment-Titration Period of Double Blind Phase
Serious events: 10 serious events
Other events: 300 other events
Deaths: 1 deaths
CAM2038 q1w or q4w BPN Treatment- Double Blind Period of Double Blind Phase
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo Subcutaneous Injections-Double Blind Period of Double Blind Phase
Serious events: 3 serious events
Other events: 32 other events
Deaths: 1 deaths
De Novo Subjects-Open Label, Titration Period Only
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Rollover Subjects-Open Label, Titration Period Only
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
De Novo Subjects-Open Label, Enrollment Period Only
Serious events: 7 serious events
Other events: 41 other events
Deaths: 0 deaths
Rollover Subjects-Open Label, Enrollment Period Only
Serious events: 7 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAM2038 q1w or q4w BPN Treatment-Titration Period of Double Blind Phase
n=468 participants at risk
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
|
CAM2038 q1w or q4w BPN Treatment- Double Blind Period of Double Blind Phase
n=112 participants at risk
CAM2038 50 mg/mL q1w at doses of 4, mg 8 mg, 12 mg, CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg. buprenorphine
|
Placebo Subcutaneous Injections-Double Blind Period of Double Blind Phase
n=110 participants at risk
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
De Novo Subjects-Open Label, Titration Period Only
n=75 participants at risk
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
|
Rollover Subjects-Open Label, Titration Period Only
n=46 participants at risk
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection
|
De Novo Subjects-Open Label, Enrollment Period Only
n=54 participants at risk
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Rollover Subjects-Open Label, Enrollment Period Only
n=55 participants at risk
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.3%
1/75 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulonary disease
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.3%
1/75 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.2%
1/46 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
1/55 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
1/55 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
1/55 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
1/55 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
1/55 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Triple negative breast cancer
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
1/55 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Nervous system disorders
Dizzyness
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
1/55 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.89%
1/112 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.89%
1/112 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/468 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.89%
1/112 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Infections and infestations
Cellulitis
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Nervous system disorders
Hemiparesis
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
General disorders
Asthenia
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
General disorders
Multi-organ failure
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/54 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
Other adverse events
| Measure |
CAM2038 q1w or q4w BPN Treatment-Titration Period of Double Blind Phase
n=468 participants at risk
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
|
CAM2038 q1w or q4w BPN Treatment- Double Blind Period of Double Blind Phase
n=112 participants at risk
CAM2038 50 mg/mL q1w at doses of 4, mg 8 mg, 12 mg, CAM2038 356 mg/mL q4w at doses of 64 mg, 96 mg, or 128 mg. buprenorphine
|
Placebo Subcutaneous Injections-Double Blind Period of Double Blind Phase
n=110 participants at risk
CAM2038 placebo: 0.16, 0.18, 0.24, 0.27, 0.36, and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
De Novo Subjects-Open Label, Titration Period Only
n=75 participants at risk
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
|
Rollover Subjects-Open Label, Titration Period Only
n=46 participants at risk
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12, 16, 24 and 32 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection
|
De Novo Subjects-Open Label, Enrollment Period Only
n=54 participants at risk
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
Rollover Subjects-Open Label, Enrollment Period Only
n=55 participants at risk
CAM2038 q1w (buprenorphine FluidCrystal®) : SC injection depot for once weekly or monthly administration at doses of 4, 8, 12 mg (buprenorphine base) 0.16, 0.24, and 0.64 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-weekly injection depot)
CAM2038 q4w ( buprenorphine FluidCrystal®): SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 mg (buprenorphine base) 0.18, 0.27, and 0.36 mL SC injection CAM2038 (buprenorphine FluidCrystal® once-monthly injection depot)
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.3%
25/468 • Number of events 25 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
2/112 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.3%
4/75 • Number of events 4 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Gastrointestinal disorders
Nausea
|
18.6%
87/468 • Number of events 87 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
2/112 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
12.0%
9/75 • Number of events 9 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
15.2%
7/46 • Number of events 7 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
7.4%
4/54 • Number of events 4 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
3.6%
2/55 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Gastrointestinal disorders
Vomiting
|
13.7%
64/468 • Number of events 64 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.7%
3/112 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
9.3%
7/75 • Number of events 7 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
8.7%
4/46 • Number of events 4 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.6%
3/54 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.5%
3/55 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
General disorders
Injection Site Erythema
|
6.8%
32/468 • Number of events 32 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
2/112 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.7%
3/110 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
8.0%
6/75 • Number of events 6 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.5%
3/55 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
General disorders
Injection site pain
|
6.2%
29/468 • Number of events 29 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.89%
1/112 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.7%
3/110 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.3%
4/75 • Number of events 4 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
3.7%
2/54 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
1/55 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
General disorders
Injection site pruritus
|
8.5%
40/468 • Number of events 40 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
8.0%
6/75 • Number of events 6 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
4.3%
2/46 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
3.7%
2/54 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.5%
3/55 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
General disorders
Injection Site Swelling
|
5.3%
25/468 • Number of events 25 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.89%
1/112 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.7%
3/110 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.3%
4/75 • Number of events 4 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.6%
3/54 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Infections and infestations
Upper respiratory tract injection
|
1.3%
6/468 • Number of events 6 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
2/112 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
3.6%
4/110 • Number of events 4 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
8.0%
6/75 • Number of events 6 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.2%
1/46 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.5%
3/55 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
General disorders
Oedema peripheral
|
1.3%
6/468 • Number of events 6 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.7%
3/112 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.5%
3/55 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Infections and infestations
Influenza
|
1.1%
5/468 • Number of events 5 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.89%
1/112 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.3%
1/75 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.2%
1/46 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
7.3%
4/55 • Number of events 4 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
7/468 • Number of events 7 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.3%
1/75 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.5%
3/55 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
1.7%
8/468 • Number of events 8 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
4.5%
5/112 • Number of events 5 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
6.4%
7/110 • Number of events 7 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.2%
1/46 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
7.4%
4/54 • Number of events 4 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
9.1%
5/55 • Number of events 5 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
3.4%
16/468 • Number of events 16 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
4.5%
5/112 • Number of events 5 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
4.0%
3/75 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.2%
1/46 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
3.7%
2/54 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.5%
3/55 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.89%
1/112 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.3%
1/75 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.6%
3/54 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Investigations
Blood glucose increased
|
0.43%
2/468 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
11.1%
6/54 • Number of events 6 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
5/468 • Number of events 5 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.6%
3/54 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
3.6%
2/55 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
15/468 • Number of events 15 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.89%
1/112 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.7%
2/75 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
10.9%
6/55 • Number of events 6 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.9%
9/468 • Number of events 9 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
6.2%
7/112 • Number of events 7 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.8%
2/110 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.3%
1/75 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.2%
1/46 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.5%
3/55 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.21%
1/468 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/110 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/46 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.6%
3/54 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Nervous system disorders
Dizziness
|
8.1%
38/468 • Number of events 38 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/112 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
2.7%
2/75 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
4.3%
2/46 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
1.9%
1/54 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/55 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
|
Nervous system disorders
Headache
|
6.0%
28/468 • Number of events 28 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.89%
1/112 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.91%
1/110 • Number of events 1 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
0.00%
0/75 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
4.3%
2/46 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
3.7%
2/54 • Number of events 2 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
5.5%
3/55 • Number of events 3 • Double Blind Phase-up to 26 weeks Open Label Phase-up to 64 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER