Trial Outcomes & Findings for Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film (NCT NCT01871285)
NCT ID: NCT01871285
Last Updated: 2017-02-27
Results Overview
A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Results posted on
2017-02-27
Participant Flow
Subjects with at least 6 months history of chronic pain requiring around-the-clock (ATC) opioid therapy with 80 to 220 mg morphine sulfate equivalent (MSE) per day for at least 28 days
Subjects were enrolled and entered a screening period (73). Those meeting criteria for study entry including positive precipitated withdrawal during naloxone challenge (39) were randomized and stratified to 2 dose groups (subjects requiring 80-160 mg MSE/day ATC to MSE Dose Group 1 and subjects requiring 161-220 mg MSE/day ATC to MSE Dose Group 2).
Participant milestones
| Measure |
MSE Dose Group 1 (AB) - Buprenorphine (300 μg) Then ATC Opioid
MSE Dose Group 1 receiving treatment sequence AB with A being buprenorphine hydrochloride (HCl) buccal film (300 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
|
MSE Dose Group 1 (BA) - ATC Opioid Then Buprenorphine (300 μg)
MSE Dose Group 1 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
|
MSE Dose Group 2 (AB) - Buprenorphine (450 μg) Then ATC Opioid
MSE Dose Group 2 receiving treatment sequence AB with A being buprenorphine HCl buccal film (450 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
|
MSE Dose Group 2 (BA) - ATC Opioid Then Buprenorphine (450 μg)
MSE Dose Group 2 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
|
|---|---|---|---|---|
|
First Intervention (1 Day)
STARTED
|
18
|
15
|
4
|
2
|
|
First Intervention (1 Day)
COMPLETED
|
17
|
14
|
3
|
2
|
|
First Intervention (1 Day)
NOT COMPLETED
|
1
|
1
|
1
|
0
|
|
Second Intervention (1 Day)
STARTED
|
17
|
14
|
3
|
2
|
|
Second Intervention (1 Day)
COMPLETED
|
17
|
14
|
3
|
2
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
MSE Dose Group 1 (AB) - Buprenorphine (300 μg) Then ATC Opioid
MSE Dose Group 1 receiving treatment sequence AB with A being buprenorphine hydrochloride (HCl) buccal film (300 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
|
MSE Dose Group 1 (BA) - ATC Opioid Then Buprenorphine (300 μg)
MSE Dose Group 1 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
|
MSE Dose Group 2 (AB) - Buprenorphine (450 μg) Then ATC Opioid
MSE Dose Group 2 receiving treatment sequence AB with A being buprenorphine HCl buccal film (450 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
|
MSE Dose Group 2 (BA) - ATC Opioid Then Buprenorphine (450 μg)
MSE Dose Group 2 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
|
|---|---|---|---|---|
|
First Intervention (1 Day)
Adverse Event
|
1
|
0
|
0
|
0
|
|
First Intervention (1 Day)
Lost to Follow-up
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film
Baseline characteristics by cohort
| Measure |
MSE Dose Group 1
n=33 Participants
Morning and evening dose of buprenorphine HCl buccal film (300 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
|
MSE Dose Group 2
n=6 Participants
Morning and evening dose of buprenorphine HCl buccal film (450 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.0 years
n=5 Participants
|
44.0 years
n=7 Participants
|
43.0 years
n=5 Participants
|
|
Gender
Female
|
17 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Gender
Male
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequencePopulation: Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS \[eg, received erroneous treatment\], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of the 2 treatment periods); 4 subjects were excluded.
A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.
Outcome measures
| Measure |
MSE Dose Group 1 - Buprenorphine
n=31 Participants
Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
|
MSE Dose Group 1 - ATC Opioid
n=31 Participants
Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
|
MSE Dose Group 2 - Buprenorphine
n=4 Participants
Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
|
MSE Dose Group 2 - ATC Opioid
n=4 Participants
Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
|
|---|---|---|---|---|
|
Number of Responders
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequencePopulation: Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS \[eg, received erroneous treatment\], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 periods); 4 subjects were excluded.
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The maximum COWs total score is defined as the maximum COWs total score across all time points during the corresponding treatment period after study drug administration for each subject.
Outcome measures
| Measure |
MSE Dose Group 1 - Buprenorphine
n=31 Participants
Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
|
MSE Dose Group 1 - ATC Opioid
n=31 Participants
Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
|
MSE Dose Group 2 - Buprenorphine
n=4 Participants
Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
|
MSE Dose Group 2 - ATC Opioid
n=4 Participants
Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
|
|---|---|---|---|---|
|
Maximum COWS Total Score
|
4.6 score
Standard Deviation 3.15
|
5.3 score
Standard Deviation 4.42
|
5.5 score
Standard Deviation 1.91
|
6.3 score
Standard Deviation 2.50
|
PRIMARY outcome
Timeframe: Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequencePopulation: Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS \[eg, received erroneous treatment\], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 treatment periods); 4 subjects were excluded.
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The change from baseline in maximum COWS total score is determined as the difference between the maximum COWs total score and the baseline COWs total score.
Outcome measures
| Measure |
MSE Dose Group 1 - Buprenorphine
n=31 Participants
Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
|
MSE Dose Group 1 - ATC Opioid
n=31 Participants
Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
|
MSE Dose Group 2 - Buprenorphine
n=4 Participants
Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
|
MSE Dose Group 2 - ATC Opioid
n=4 Participants
Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
|
|---|---|---|---|---|
|
Change From Baseline in Maximum COWS Total Score
|
4.0 score
Standard Deviation 2.92
|
3.9 score
Standard Deviation 4.11
|
4.5 score
Standard Deviation 1.73
|
4.3 score
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequencePopulation: Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS \[eg, received erroneous treatment\], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 treatment periods); 4 subjects were excluded.
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.
Outcome measures
| Measure |
MSE Dose Group 1 - Buprenorphine
n=31 Participants
Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
|
MSE Dose Group 1 - ATC Opioid
n=31 Participants
Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
|
MSE Dose Group 2 - Buprenorphine
n=4 Participants
Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
|
MSE Dose Group 2 - ATC Opioid
n=4 Participants
Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
|
|---|---|---|---|---|
|
Change From Baseline in COWS Total Score Over Time
Hour 12.5
|
1.0 score
Standard Deviation 1.32
|
0.5 score
Standard Deviation 2.01
|
3.0 score
Standard Deviation 3.56
|
1.3 score
Standard Deviation 4.27
|
|
Change From Baseline in COWS Total Score Over Time
Hour 13
|
0.9 score
Standard Deviation 1.26
|
0.5 score
Standard Deviation 1.72
|
3.3 score
Standard Deviation 3.77
|
0.0 score
Standard Deviation 3.83
|
|
Change From Baseline in COWS Total Score Over Time
Hour 13.5
|
1.0 score
Standard Deviation 1.76
|
0.4 score
Standard Deviation 1.80
|
1.8 score
Standard Deviation 2.63
|
-0.3 score
Standard Deviation 3.40
|
|
Change From Baseline in COWS Total Score Over Time
Hour 14
|
0.7 score
Standard Deviation 1.33
|
0.2 score
Standard Deviation 2.06
|
3.3 score
Standard Deviation 3.10
|
-0.3 score
Standard Deviation 3.10
|
|
Change From Baseline in COWS Total Score Over Time
Hour 16
|
0.5 score
Standard Deviation 1.55
|
-0.1 score
Standard Deviation 1.88
|
1.8 score
Standard Deviation 2.06
|
-0.3 score
Standard Deviation 3.10
|
|
Change From Baseline in COWS Total Score Over Time
Hour 24
|
1.8 score
Standard Deviation 3.13
|
0.7 score
Standard Deviation 3.12
|
2.0 score
Standard Deviation 2.58
|
2.8 score
Standard Deviation 2.63
|
|
Change From Baseline in COWS Total Score Over Time
Hour 0.5
|
0.1 score
Standard Deviation 0.67
|
-0.3 score
Standard Deviation 1.47
|
0.0 score
Standard Deviation 0.82
|
-1.3 score
Standard Deviation 0.96
|
|
Change From Baseline in COWS Total Score Over Time
Hour 1
|
0.3 score
Standard Deviation 1.04
|
0.0 score
Standard Deviation 1.94
|
0.8 score
Standard Deviation 1.50
|
-1.0 score
Standard Deviation 1.41
|
|
Change From Baseline in COWS Total Score Over Time
Hour 1.5
|
0.4 score
Standard Deviation 1.31
|
0.2 score
Standard Deviation 2.50
|
0.5 score
Standard Deviation 1.29
|
-1.0 score
Standard Deviation 1.41
|
|
Change From Baseline in COWS Total Score Over Time
Hour 2
|
0.3 score
Standard Deviation 0.90
|
0.2 score
Standard Deviation 2.48
|
1.8 score
Standard Deviation 1.50
|
-1.0 score
Standard Deviation 0.82
|
|
Change From Baseline in COWS Total Score Over Time
Hour 2.5
|
0.6 score
Standard Deviation 1.41
|
0.3 score
Standard Deviation 2.32
|
1.3 score
Standard Deviation 1.26
|
-1.0 score
Standard Deviation 0.82
|
|
Change From Baseline in COWS Total Score Over Time
Hour 3
|
0.6 score
Standard Deviation 1.72
|
0.2 score
Standard Deviation 2.49
|
0.3 score
Standard Deviation 0.96
|
-1.0 score
Standard Deviation 1.63
|
|
Change From Baseline in COWS Total Score Over Time
Hour 3.5
|
0.9 score
Standard Deviation 1.81
|
0.3 score
Standard Deviation 2.17
|
1.5 score
Standard Deviation 1.73
|
-0.8 score
Standard Deviation 1.71
|
|
Change From Baseline in COWS Total Score Over Time
Hour 4
|
0.8 score
Standard Deviation 1.54
|
0.4 score
Standard Deviation 2.48
|
1.0 score
Standard Deviation 1.15
|
-1.0 score
Standard Deviation 1.83
|
|
Change From Baseline in COWS Total Score Over Time
Hour 6
|
0.6 score
Standard Deviation 1.58
|
0.6 score
Standard Deviation 2.76
|
1.0 score
Standard Deviation 1.15
|
0.0 score
Standard Deviation 2.58
|
|
Change From Baseline in COWS Total Score Over Time
Hour 9
|
0.9 score
Standard Deviation 1.47
|
1.4 score
Standard Deviation 3.64
|
1.3 score
Standard Deviation 1.26
|
1.0 score
Standard Deviation 1.15
|
|
Change From Baseline in COWS Total Score Over Time
Hour 12
|
2.1 score
Standard Deviation 2.38
|
1.5 score
Standard Deviation 3.43
|
3.3 score
Standard Deviation 2.50
|
0.3 score
Standard Deviation 3.77
|
SECONDARY outcome
Timeframe: Pre-dose (-0.5; baseline), 0.5, 1, 2, 4, 9, 12, 12.5, 13, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequencePopulation: Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS \[eg, received erroneous treatment\], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of the 2 treatment periods); 4 subjects excluded.
Subject rating of pain intensity using 11-point numerical rating scale (NRS) where 0=no pain and 10=pain as bad as you can imagine.
Outcome measures
| Measure |
MSE Dose Group 1 - Buprenorphine
n=31 Participants
Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
|
MSE Dose Group 1 - ATC Opioid
n=31 Participants
Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
|
MSE Dose Group 2 - Buprenorphine
n=4 Participants
Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
|
MSE Dose Group 2 - ATC Opioid
n=4 Participants
Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
|
|---|---|---|---|---|
|
Change From Baseline in "Pain Now" Over Time Using NRS
Hour 0.5
|
-0.3 units on a scale
Standard Deviation 1.24
|
-0.6 units on a scale
Standard Deviation 0.92
|
-0.5 units on a scale
Standard Deviation 1.73
|
-1.3 units on a scale
Standard Deviation 0.50
|
|
Change From Baseline in "Pain Now" Over Time Using NRS
Hour 1
|
-0.5 units on a scale
Standard Deviation 1.43
|
-1.1 units on a scale
Standard Deviation 1.30
|
0.3 units on a scale
Standard Deviation 1.26
|
-1.5 units on a scale
Standard Deviation 1.00
|
|
Change From Baseline in "Pain Now" Over Time Using NRS
Hour 2
|
-0.7 units on a scale
Standard Deviation 1.37
|
-1.2 units on a scale
Standard Deviation 1.49
|
0.8 units on a scale
Standard Deviation 0.96
|
-1.3 units on a scale
Standard Deviation 1.50
|
|
Change From Baseline in "Pain Now" Over Time Using NRS
Hour 4
|
-0.9 units on a scale
Standard Deviation 1.97
|
-1.0 units on a scale
Standard Deviation 1.80
|
0.5 units on a scale
Standard Deviation 1.73
|
-1.8 units on a scale
Standard Deviation 2.06
|
|
Change From Baseline in "Pain Now" Over Time Using NRS
Hour 9
|
-0.5 units on a scale
Standard Deviation 2.29
|
-0.1 units on a scale
Standard Deviation 1.97
|
1.0 units on a scale
Standard Deviation 1.41
|
-0.8 units on a scale
Standard Deviation 2.06
|
|
Change From Baseline in "Pain Now" Over Time Using NRS
Hour 12
|
0.5 units on a scale
Standard Deviation 2.13
|
0.3 units on a scale
Standard Deviation 2.01
|
1.5 units on a scale
Standard Deviation 1.91
|
-0.3 units on a scale
Standard Deviation 2.63
|
|
Change From Baseline in "Pain Now" Over Time Using NRS
Hour 12.5
|
0.0 units on a scale
Standard Deviation 2.29
|
-0.4 units on a scale
Standard Deviation 2.01
|
1.0 units on a scale
Standard Deviation 2.16
|
-0.3 units on a scale
Standard Deviation 2.99
|
|
Change From Baseline in "Pain Now" Over Time Using NRS
Hour 13
|
-0.4 units on a scale
Standard Deviation 2.40
|
-0.7 units on a scale
Standard Deviation 2.07
|
0.8 units on a scale
Standard Deviation 1.89
|
-0.8 units on a scale
Standard Deviation 2.99
|
|
Change From Baseline in "Pain Now" Over Time Using NRS
Hour 14
|
-0.7 units on a scale
Standard Deviation 2.24
|
-1.2 units on a scale
Standard Deviation 2.02
|
1.0 units on a scale
Standard Deviation 2.16
|
-1.0 units on a scale
Standard Deviation 3.37
|
|
Change From Baseline in "Pain Now" Over Time Using NRS
Hour 16
|
-0.9 units on a scale
Standard Deviation 2.37
|
-1.4 units on a scale
Standard Deviation 2.03
|
0.3 units on a scale
Standard Deviation 2.22
|
-1.3 units on a scale
Standard Deviation 3.30
|
|
Change From Baseline in "Pain Now" Over Time Using NRS
Hour 24
|
-0.2 units on a scale
Standard Deviation 2.45
|
-0.2 units on a scale
Standard Deviation 2.12
|
0.8 units on a scale
Standard Deviation 2.99
|
0.0 units on a scale
Standard Deviation 2.94
|
Adverse Events
MSE Dose Group 1 - Buprenorphine
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
MSE Dose Group 1 - ATC Opioid
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
MSE Dose Group 2 - Buprenorphine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MSE Dose Group 2 - ATC Opioid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MSE Dose Group 1 - Buprenorphine
n=32 participants at risk
Subjects in MSE Dose Group 1 who received at least one 300-μg buprenorphine HCl buccal film in either period
|
MSE Dose Group 1 - ATC Opioid
n=32 participants at risk
Subjects in MSE Dose Group 1 who received at least 1 dose of assigned ATC opioid in either period
|
MSE Dose Group 2 - Buprenorphine
n=6 participants at risk
Subjects in MSE Dose Group 2 who received at least one 450-μg buprenorphine HCl buccal film in either period
|
MSE Dose Group 2 - ATC Opioid
n=5 participants at risk
Subjects in MSE Dose Group 2 who received at least 1 dose of assigned ATC opioid in either period
|
|---|---|---|---|---|
|
General disorders
Chest pain
|
3.1%
1/32 • Number of events 1 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/32 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/6 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/5 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
1/32 • Number of events 1 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/32 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/6 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/5 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
Other adverse events
| Measure |
MSE Dose Group 1 - Buprenorphine
n=32 participants at risk
Subjects in MSE Dose Group 1 who received at least one 300-μg buprenorphine HCl buccal film in either period
|
MSE Dose Group 1 - ATC Opioid
n=32 participants at risk
Subjects in MSE Dose Group 1 who received at least 1 dose of assigned ATC opioid in either period
|
MSE Dose Group 2 - Buprenorphine
n=6 participants at risk
Subjects in MSE Dose Group 2 who received at least one 450-μg buprenorphine HCl buccal film in either period
|
MSE Dose Group 2 - ATC Opioid
n=5 participants at risk
Subjects in MSE Dose Group 2 who received at least 1 dose of assigned ATC opioid in either period
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
3/32 • Number of events 3 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
3.1%
1/32 • Number of events 1 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/6 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/5 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • Number of events 3 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
6.2%
2/32 • Number of events 2 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/6 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/5 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
4/32 • Number of events 4 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
3.1%
1/32 • Number of events 1 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/6 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/5 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
|
General disorders
Drug withdrawal syndrome
|
9.4%
3/32 • Number of events 3 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
12.5%
4/32 • Number of events 4 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
16.7%
1/6 • Number of events 1 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/5 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
|
Nervous system disorders
Headache
|
18.8%
6/32 • Number of events 8 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
15.6%
5/32 • Number of events 5 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/6 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
0.00%
0/5 • From screening through follow-up contact 7-14 days after last dose (up to 7 weeks)
Analysis based on Safety population; all subjects who received at least 1 dose of double-blind, double-dummy treatment
|
Additional Information
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Restriction type: OTHER