Trial Outcomes & Findings for A Multiple Dose Opioid Challenge Study (NCT NCT02611752)
NCT ID: NCT02611752
Last Updated: 2019-11-14
Results Overview
Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
17 days
Results posted on
2019-11-14
Participant Flow
Participant milestones
| Measure |
CAM2038 q1w, 24 mg
CAM2038 once weekly 24 mg subcutaneous injection will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg intramuscular injection will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13
|
CAM2038 q1w, 32 mg
CAM2038 once weekly 32 mg subcutaneous injection will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg intramuscular injection will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
25
|
|
Overall Study
Day 1-3 Hydromorphone Challenge Injs
|
22
|
25
|
|
Overall Study
Day 4-6 Hydromorphone Challenge Injs
|
22
|
24
|
|
Overall Study
Day 8-10 Hydromorphone Challenge Injs
|
22
|
24
|
|
Overall Study
Day11-13 Hydromorphone Challenge Injs
|
22
|
24
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
CAM2038 q1w, 24 mg
CAM2038 once weekly 24 mg subcutaneous injection will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg intramuscular injection will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13
|
CAM2038 q1w, 32 mg
CAM2038 once weekly 32 mg subcutaneous injection will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg intramuscular injection will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Multiple Dose Opioid Challenge Study
Baseline characteristics by cohort
| Measure |
CAM2038 q1w, 24 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 32 mg
n=25 Participants
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
35.8 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI, kg/m^2
|
25.2 kg/m^2
STANDARD_DEVIATION 4.28 • n=5 Participants
|
24.4 kg/m^2
STANDARD_DEVIATION 4.25 • n=7 Participants
|
24.8 kg/m^2
STANDARD_DEVIATION 4.24 • n=5 Participants
|
PRIMARY outcome
Timeframe: 17 daysPopulation: Mean Drug Liking VAS Scores over Time for CAM2038 q1w 24 mg by Hydromorphone Challenge Session, Completer Population (N=22)
Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Outcome measures
| Measure |
CAM2038 q1w, 24 mg - Hydromorphone 0 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 6 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|---|
|
Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg
Baseline
|
50.6 units on a scale
Standard Error 1.48
|
83.2 units on a scale
Standard Error 1.48
|
92.7 units on a scale
Standard Error 1.48
|
|
Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg
Days 1-3
|
51.3 units on a scale
Standard Error 0.84
|
52.2 units on a scale
Standard Error 0.84
|
53.1 units on a scale
Standard Error 0.84
|
|
Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg
Days 4-6
|
50.8 units on a scale
Standard Error 0.84
|
52.1 units on a scale
Standard Error 0.84
|
58.3 units on a scale
Standard Error 0.84
|
|
Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg
Days 8 -10
|
51.1 units on a scale
Standard Error 0.84
|
52.6 units on a scale
Standard Error 0.84
|
52.9 units on a scale
Standard Error 0.84
|
|
Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg
Days 11-13
|
51.0 units on a scale
Standard Error 0.84
|
51.9 units on a scale
Standard Error 0.84
|
54.6 units on a scale
Standard Error 0.84
|
PRIMARY outcome
Timeframe: 17 daysPopulation: Mean Drug Liking VAS Scores over Time for CAM2038 q1w 32 mg by Hydromorphone Challenge Session, Completer Population (N=24)
Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population), where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Outcome measures
| Measure |
CAM2038 q1w, 24 mg - Hydromorphone 0 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 6 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|---|
|
Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg
Baseline
|
52.9 units on a scale
Standard Error 1.70
|
79.6 units on a scale
Standard Error 1.70
|
93.2 units on a scale
Standard Error 1.70
|
|
Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg
Days 1-3
|
51.6 units on a scale
Standard Error 1.01
|
52.5 units on a scale
Standard Error 1.01
|
54.0 units on a scale
Standard Error 1.01
|
|
Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg
Days 4-6
|
51.5 units on a scale
Standard Error 1.01
|
53.0 units on a scale
Standard Error 1.01
|
56.0 units on a scale
Standard Error 1.01
|
|
Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg
Days 8 -10
|
51.7 units on a scale
Standard Error 1.01
|
52.3 units on a scale
Standard Error 1.01
|
54.2 units on a scale
Standard Error 1.01
|
|
Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg
Days 11-13
|
51.2 units on a scale
Standard Error 1.01
|
52.1 units on a scale
Standard Error 1.01
|
54.8 units on a scale
Standard Error 1.01
|
PRIMARY outcome
Timeframe: 17 daysPopulation: Mean Drug Liking VAS Scores over Time for CAM2038 q1w 24 mg by Hydromorphone Challenge Session, Completer Population (N=22)
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Outcome measures
| Measure |
CAM2038 q1w, 24 mg - Hydromorphone 0 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 6 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|---|
|
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg
Qualification/Baseline
|
32.7 units on a scale
Standard Error 1.90
|
42.1 units on a scale
Standard Error 1.90
|
9.5 units on a scale
Standard Error 1.90
|
|
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg
Days 1-3
|
0.9 units on a scale
Standard Error 1.12
|
1.8 units on a scale
Standard Error 1.12
|
0.9 units on a scale
Standard Error 1.12
|
|
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg
Days 4-6
|
1.3 units on a scale
Standard Error 1.12
|
7.4 units on a scale
Standard Error 1.12
|
6.2 units on a scale
Standard Error 1.12
|
|
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg
Days 8 -10
|
1.5 units on a scale
Standard Error 1.12
|
1.8 units on a scale
Standard Error 1.12
|
0.3 units on a scale
Standard Error 1.12
|
|
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg
Days 11-13
|
0.9 units on a scale
Standard Error 1.12
|
3.6 units on a scale
Standard Error 1.12
|
2.7 units on a scale
Standard Error 1.12
|
PRIMARY outcome
Timeframe: 17 daysPopulation: Mean Drug Liking VAS Scores over Time for CAM2038 q1w 32 mg by Hydromorphone Challenge Session, Completer Population (N=24)
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 32 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Outcome measures
| Measure |
CAM2038 q1w, 24 mg - Hydromorphone 0 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 6 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|---|
|
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg
Qualification/Baseline
|
26.7 units on a scale
Standard Error 2.40
|
40.3 units on a scale
Standard Error 2.40
|
13.7 units on a scale
Standard Error 2.40
|
|
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg
Days 1-3
|
0.9 units on a scale
Standard Error 1.05
|
2.4 units on a scale
Standard Error 1.05
|
1.5 units on a scale
Standard Error 1.05
|
|
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg
Days 4-6
|
1.5 units on a scale
Standard Error 1.05
|
4.5 units on a scale
Standard Error 1.05
|
3.0 units on a scale
Standard Error 1.05
|
|
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg
Days 8 -10
|
0.5 units on a scale
Standard Error 1.05
|
2.5 units on a scale
Standard Error 1.05
|
2.0 units on a scale
Standard Error 1.05
|
|
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg
Days 11-13
|
1.0 units on a scale
Standard Error 1.05
|
3.6 units on a scale
Standard Error 1.05
|
2.6 units on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: 15 daysPopulation: Completer Population
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I feel high" where values can range from 0 (Not at all High) to 100 (Extremely High).
Outcome measures
| Measure |
CAM2038 q1w, 24 mg - Hydromorphone 0 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 6 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|---|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO 6mg-HMO 0mg
|
62.4 units on a scale
Interval 53.7 to 71.2
|
47.3 units on a scale
Interval 35.8 to 58.7
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO18mg-HMO 0 mg
|
84.6 units on a scale
Interval 75.8 to 93.3
|
77.0 units on a scale
Interval 65.5 to 88.4
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO 18mg - HMO 6mg
|
22.2 units on a scale
Interval 13.4 to 30.9
|
29.7 units on a scale
Interval 18.3 to 41.2
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 6mg - HMO 0mg
|
4.3 units on a scale
Interval -0.4 to 9.0
|
3.1 units on a scale
Interval -0.4 to 6.6
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 18mg - HMO 0mg
|
3.6 units on a scale
Interval -1.1 to 8.3
|
3.2 units on a scale
Interval -0.3 to 6.7
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 18mg-HMO 6mg
|
-0.8 units on a scale
Interval -5.4 to 3.9
|
0.1 units on a scale
Interval -3.4 to 3.6
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 6mg - HMO 0mg
|
1.8 units on a scale
Interval -2.9 to 6.5
|
1.5 units on a scale
Interval -2.0 to 5.1
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 18mg - HMO 0mg
|
15.3 units on a scale
Interval 10.6 to 20.0
|
6.5 units on a scale
Interval 3.0 to 10.1
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 18mg - HMO 6mg
|
13.5 units on a scale
Interval 8.8 to 18.2
|
5.0 units on a scale
Interval 1.5 to 8.6
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO6mg - HMO 0mg
|
2.6 units on a scale
Interval -2.1 to 7.2
|
0.9 units on a scale
Interval -2.6 to 4.5
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO 18mg - HMO 0mg
|
3.9 units on a scale
Interval -0.8 to 8.5
|
5.4 units on a scale
Interval 1.9 to 9.0
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO 18mg - HMO 6mg
|
1.3 units on a scale
Interval -3.4 to 6.0
|
4.5 units on a scale
Interval 1.0 to 8.1
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 6mg - HMO 0mg
|
2.1 units on a scale
Interval -2.6 to 6.8
|
1.3 units on a scale
Interval -2.2 to 4.8
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 18mg - HMO 0mg
|
6.4 units on a scale
Interval 1.7 to 11.0
|
6.0 units on a scale
Interval 2.4 to 9.5
|
—
|
|
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 18mg - HMO 6mg
|
4.2 units on a scale
Interval -0.4 to 8.9
|
4.7 units on a scale
Interval 1.1 to 8.2
|
—
|
SECONDARY outcome
Timeframe: 15 daysPopulation: Completer Population
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseling and four challenge sequences with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I feel good drug effects" where values can range from 0 (Not at all ) to 100 (Extremely).
Outcome measures
| Measure |
CAM2038 q1w, 24 mg - Hydromorphone 0 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 6 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|---|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO 6mg-HMO 0mg
|
61.6 units on a scale
Interval 52.5 to 70.7
|
52.8 units on a scale
Interval 43.3 to 62.3
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO 18mg-HMO 0mg
|
85.4 units on a scale
Interval 76.4 to 94.5
|
81.8 units on a scale
Interval 72.3 to 91.4
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO18mg-HMO 6mg
|
23.9 units on a scale
Interval 14.8 to 32.9
|
29.1 units on a scale
Interval 19.6 to 38.6
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 6mg - HMO 0mg
|
0.8 units on a scale
Interval -5.1 to 6.6
|
2.8 units on a scale
Interval -1.1 to 6.7
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 18mg - HMO 0mg
|
1.3 units on a scale
Interval -4.5 to 7.2
|
4.9 units on a scale
Interval 1.0 to 8.8
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 18mg-HMO 6mg
|
0.6 units on a scale
Interval -5.3 to 6.4
|
2.1 units on a scale
Interval -1.8 to 6.0
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 6mg - HMO 0mg
|
1.8 units on a scale
Interval -4.0 to 7.7
|
1.7 units on a scale
Interval -2.2 to 5.6
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 18mg - HMO 0mg
|
15.8 units on a scale
Interval 10.0 to 21.7
|
7.3 units on a scale
Interval 3.4 to 11.2
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO18mg - HMO 6mg
|
14.0 units on a scale
Interval 8.1 to 19.8
|
5.6 units on a scale
Interval 1.7 to 9.5
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO6mg - HMO 0mg
|
2.4 units on a scale
Interval -3.4 to 8.2
|
0.8 units on a scale
Interval -3.1 to 4.7
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO 18mg - HMO 0mg
|
4.7 units on a scale
Interval -1.2 to 10.5
|
4.9 units on a scale
Interval 1.0 to 8.9
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO 18mg - HMO 6mg
|
2.3 units on a scale
Interval -3.5 to 8.1
|
4.1 units on a scale
Interval 0.2 to 8.1
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO 6mg - HMO 0mg
|
2.2 units on a scale
Interval -3.6 to 8.0
|
0.7 units on a scale
Interval -3.2 to 4.7
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 18mg - HMO 0mg
|
7.1 units on a scale
Interval 1.3 to 13.0
|
6.0 units on a scale
Interval 2.1 to 9.9
|
—
|
|
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 18mg - HMO 6mg
|
4.9 units on a scale
Interval -0.9 to 10.8
|
5.2 units on a scale
Interval 1.3 to 9.2
|
—
|
SECONDARY outcome
Timeframe: 15 daysPopulation: Completer Population
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, I feel bad effects" where values can range from 0 (Not at all) to 100 (Extremely).
Outcome measures
| Measure |
CAM2038 q1w, 24 mg - Hydromorphone 0 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 6 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|---|
|
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)
Baseline
|
3.0 units on a scale
Standard Error 3.18
|
8.4 units on a scale
Standard Error 3.18
|
13.1 units on a scale
Standard Error 3.18
|
|
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)
Challenge Session 1 (Days 1-3)
|
5.0 units on a scale
Standard Error 1.17
|
0.9 units on a scale
Standard Error 1.17
|
0.8 units on a scale
Standard Error 1.17
|
|
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)
Challenge Session 2 (Days 4-6)
|
1.5 units on a scale
Standard Error 1.17
|
0.8 units on a scale
Standard Error 1.17
|
1.6 units on a scale
Standard Error 1.17
|
|
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)
Challenge Session 3 (Days 8-10)
|
0.8 units on a scale
Standard Error 1.17
|
0.7 units on a scale
Standard Error 1.17
|
1.6 units on a scale
Standard Error 1.17
|
|
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)
Challenge Session 4 (Days 11-13)
|
1.0 units on a scale
Standard Error 1.17
|
1.0 units on a scale
Standard Error 1.17
|
0.9 units on a scale
Standard Error 1.17
|
SECONDARY outcome
Timeframe: 15 daysPopulation: Completer Population
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, I feel bad effects" where values can range from 0 (Not at all) to 100 (Extremely).
Outcome measures
| Measure |
CAM2038 q1w, 24 mg - Hydromorphone 0 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 6 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|---|
|
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)
Baseline
|
5.9 units on a scale
Standard Error 3.47
|
13.1 units on a scale
Standard Error 3.47
|
12.6 units on a scale
Standard Error 3.47
|
|
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)
Challenge Session 1 (Days 1-3)
|
1.2 units on a scale
Standard Error 0.67
|
1.3 units on a scale
Standard Error 0.67
|
1.4 units on a scale
Standard Error 0.67
|
|
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)
Challenge Session 2 (Days 4-6)
|
0.5 units on a scale
Standard Error 0.67
|
1.4 units on a scale
Standard Error 0.67
|
2.1 units on a scale
Standard Error 0.67
|
|
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)
Challenge Session 3 (Days 8-10)
|
0.6 units on a scale
Standard Error 0.67
|
0.8 units on a scale
Standard Error 0.67
|
2.8 units on a scale
Standard Error 0.67
|
|
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)
Challenge Session 4 (Days 11-13)
|
0.6 units on a scale
Standard Error 0.67
|
1.0 units on a scale
Standard Error 0.67
|
1.3 units on a scale
Standard Error 0.67
|
SECONDARY outcome
Timeframe: 15 daysPopulation: (Completer Population)
Analysis Results for Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I desire opiods" where values can range from 0 (Definitely not) to 100 (Definitely so).
Outcome measures
| Measure |
CAM2038 q1w, 24 mg - Hydromorphone 0 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 6 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|---|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO 6mg-HMO 0mg
|
-18.0 units on a scale
Standard Error 4.50
|
14.1 units on a scale
Standard Error 3.76
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO 18mg-HMO 0mg
|
-31.0 units on a scale
Standard Error 4.50
|
-29.2 units on a scale
Standard Error 3.75
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO18mg-HMO 6mg
|
013.0 units on a scale
Standard Error 4.50
|
-15.1 units on a scale
Standard Error 3.75
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 6mg - HMO 0mg
|
-0.2 units on a scale
Standard Error 4.03
|
8.7 units on a scale
Standard Error 5.09
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 18mg - HMO 0mg
|
1.8 units on a scale
Standard Error 4.03
|
-5.7 units on a scale
Standard Error 5.08
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 18mg-HMO 6mg
|
2.0 units on a scale
Standard Error 4.03
|
-14.4 units on a scale
Standard Error 5.08
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 6mg - HMO 0mg
|
-3.8 units on a scale
Standard Error 4.03
|
-3.1 units on a scale
Standard Error 5.09
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 18mg - HMO 0mg
|
-6.2 units on a scale
Standard Error 4.03
|
0.7 units on a scale
Standard Error 5.08
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 18mg - HMO 6mg
|
-2.4 units on a scale
Standard Error 4.03
|
3.7 units on a scale
Standard Error 5.08
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO6mg - HMO 0mg
|
-2.8 units on a scale
Standard Error 4.03
|
2.2 units on a scale
Standard Error 5.09
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO 18mg - HMO 0mg
|
-1.8 units on a scale
Standard Error 4.03
|
0.4 units on a scale
Standard Error 5.08
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO 18mg - HMO 6mg
|
1.0 units on a scale
Standard Error 4.03
|
-1.8 units on a scale
Standard Error 5.08
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 6mg - HMO 0mg
|
-2.2 units on a scale
Standard Error 4.03
|
-0.2 units on a scale
Standard Error 5.09
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 18mg - HMO 0mg
|
-4.5 units on a scale
Standard Error 4.03
|
0.9 units on a scale
Standard Error 5.08
|
—
|
|
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 18mg - HMO 6mg
|
-2.3 units on a scale
Standard Error 4.03
|
1.1 units on a scale
Standard Error 5.08
|
—
|
SECONDARY outcome
Timeframe: 15 daysPopulation: (Completer Population)
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, my mental state is" where values can range from 0 (Very Drowsy) to 100 (Very alert), with 50 being neutral (Neither drowsy nor alert).
Outcome measures
| Measure |
CAM2038 q1w, 24 mg - Hydromorphone 0 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 6 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|---|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO 6mg-HMO 0mg
|
-18.0 units on a scale
Standard Error 4.5
|
-14.1 units on a scale
Standard Error 3.76
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO 18mg-HMO 0mg
|
-31.0 units on a scale
Standard Error 4.50
|
-29.2 units on a scale
Standard Error 3.75
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO18mg-HMO 6mg
|
-13.0 units on a scale
Standard Error 4.50
|
-15.1 units on a scale
Standard Error 3.75
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 6mg - HMO 0mg
|
-2.2 units on a scale
Standard Error 3.89
|
1.7 units on a scale
Standard Error 3.05
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 18mg - HMO 0mg
|
-4.9 units on a scale
Standard Error 3.89
|
-0.8 units on a scale
Standard Error 3.05
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 18mg-HMO 6mg
|
-2.8 units on a scale
Standard Error 3.89
|
-2.5 units on a scale
Standard Error 3.05
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 6mg - HMO 0mg
|
-6.2 units on a scale
Standard Error 3.89
|
-2.0 units on a scale
Standard Error 3.05
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 18mg - HMO 0mg
|
-8.3 units on a scale
Standard Error 3.89
|
-2.7 units on a scale
Standard Error 3.05
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 18mg - HMO 6mg
|
-2.1 units on a scale
Standard Error 3.89
|
-0.7 units on a scale
Standard Error 3.05
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO6mg - HMO 0mg
|
-0.2 units on a scale
Standard Error 3.89
|
-0.9 units on a scale
Standard Error 3.05
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO 18mg - HMO 0mg
|
-7.5 units on a scale
Standard Error 3.89
|
-4.3 units on a scale
Standard Error 3.05
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO 18mg - HMO 6mg
|
-7.4 units on a scale
Standard Error 3.89
|
-3.4 units on a scale
Standard Error 3.05
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 6mg - HMO 0mg
|
0.7 units on a scale
Standard Error 3.89
|
1.8 units on a scale
Standard Error 3.05
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 18mg - HMO 0mg
|
-2.1 units on a scale
Standard Error 3.89
|
-0.2 units on a scale
Standard Error 3.05
|
—
|
|
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 18mg - HMO 6mg
|
-2.8 units on a scale
Standard Error 3.89
|
-2.0 units on a scale
Standard Error 3.05
|
—
|
SECONDARY outcome
Timeframe: 15 daysPopulation: (Completer Population)
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, I fell any drug effects" where values can range from 0 (Not at all) to 100 (Extremely).
Outcome measures
| Measure |
CAM2038 q1w, 24 mg - Hydromorphone 0 mg
n=22 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 6 mg
n=24 Participants
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 24 mg - Hydromorphone 18 mg
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|---|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO 6mg-HMO 0mg
|
63.2 units on a scale
Standard Error 4.49
|
47.8 units on a scale
Standard Error 5.25
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO 18mg-HMO 0mg
|
83.9 units on a scale
Standard Error 4.49
|
76.4 units on a scale
Standard Error 5.24
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Baseline HMO18mg-HMO 6mg
|
20.7 units on a scale
Standard Error 4.49
|
28.6 units on a scale
Standard Error 5.24
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 6mg - HMO 0mg
|
4.0 units on a scale
Standard Error 2.27
|
3.2 units on a scale
Standard Error 2.36
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 18mg - HMO 0mg
|
3.5 units on a scale
Standard Error 2.27
|
6.8 units on a scale
Standard Error 2.35
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 1 HMO 18mg-HMO 6mg
|
-0.5 units on a scale
Standard Error 2.27
|
3.6 units on a scale
Standard Error 2.35
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 6mg - HMO 0mg
|
1.6 units on a scale
Standard Error 2.27
|
3.6 units on a scale
Standard Error 2.36
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 18mg - HMO 0mg
|
13.6 units on a scale
Standard Error 2.27
|
5.9 units on a scale
Standard Error 2.35
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 2 HMO 18mg - HMO 6mg
|
11.9 units on a scale
Standard Error 2.27
|
2.2 units on a scale
Standard Error 2.35
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO6mg - HMO 0mg
|
2.4 units on a scale
Standard Error 2.27
|
-1.1 units on a scale
Standard Error 2.36
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO 18mg - HMO 0mg
|
4.6 units on a scale
Standard Error 2.27
|
3.3 units on a scale
Standard Error 2.35
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 3 HMO 18mg - HMO 6mg
|
2.2 units on a scale
Standard Error 2.27
|
4.4 units on a scale
Standard Error 2.35
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 6mg - HMO 0mg
|
1.5 units on a scale
Standard Error 2.27
|
-1.1 units on a scale
Standard Error 2.36
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 18mg - HMO 0mg
|
6.9 units on a scale
Standard Error 2.27
|
2.1 units on a scale
Standard Error 2.35
|
—
|
|
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Challenge Session 4 HMO 18mg - HMO 6mg
|
5.4 units on a scale
Standard Error 2.27
|
3.2 units on a scale
Standard Error 2.35
|
—
|
Adverse Events
CAM2038 q1w, 24 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
CAM2038 q1w, 32 mg
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CAM2038 q1w, 24 mg
n=22 participants at risk
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg, and 18 mg intramuscular injections each being administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
CAM2038 q1w, 32 mg
n=25 participants at risk
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg, and 18 mg intramuscular injections each being administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
13.6%
3/22 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
24.0%
6/25 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
12.0%
3/25 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
|
Gastrointestinal disorders
Faeces Hard
|
0.00%
0/22 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
8.0%
2/25 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
|
General disorders
Injection Site Pain
|
9.1%
2/22 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
12.0%
3/25 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
|
General disorders
Injection Site Erythema
|
9.1%
2/22 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
8.0%
2/25 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
|
General disorders
Injection Site Pruritus
|
4.5%
1/22 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
8.0%
2/25 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
|
General disorders
Injection site Haemorrhage
|
0.00%
0/22 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
8.0%
2/25 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contac
|
4.5%
1/22 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
8.0%
2/25 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/22 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
8.0%
2/25 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
4.0%
1/25 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/22 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
8.0%
2/25 • All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place