Trial Outcomes & Findings for Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain (NCT NCT01256450)
NCT ID: NCT01256450
Last Updated: 2017-02-27
Results Overview
Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
334 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2017-02-27
Participant Flow
Of 334 subjects who were enrolled in the open-label (OL) titration phase; a total of 235 completed the open-label titration phase and were randomized in the double-blind (DB) treatment phase.
Participant milestones
| Measure |
OL Buprenorphine HCl Buccal Film
Buprenorphine hydrochloride (HCl) buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
|
DB Buprenorphine HCl Buccal Film
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|---|
|
Open-label Titration
STARTED
|
334
|
0
|
0
|
|
Open-label Titration
COMPLETED
|
235
|
0
|
0
|
|
Open-label Titration
NOT COMPLETED
|
99
|
0
|
0
|
|
Double-blind Treatment
STARTED
|
0
|
117
|
118
|
|
Double-blind Treatment
COMPLETED
|
0
|
89
|
81
|
|
Double-blind Treatment
NOT COMPLETED
|
0
|
28
|
37
|
Reasons for withdrawal
| Measure |
OL Buprenorphine HCl Buccal Film
Buprenorphine hydrochloride (HCl) buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
|
DB Buprenorphine HCl Buccal Film
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|---|
|
Open-label Titration
Adverse Event
|
39
|
0
|
0
|
|
Open-label Titration
Lost to Follow-up
|
7
|
0
|
0
|
|
Open-label Titration
Lack of analgesic effect
|
30
|
0
|
0
|
|
Open-label Titration
Non-compliance
|
9
|
0
|
0
|
|
Open-label Titration
Screen failure
|
1
|
0
|
0
|
|
Open-label Titration
Other
|
13
|
0
|
0
|
|
Double-blind Treatment
Adverse Event
|
0
|
8
|
6
|
|
Double-blind Treatment
Lost to Follow-up
|
0
|
1
|
7
|
|
Double-blind Treatment
Withdrawal by Subject
|
0
|
0
|
1
|
|
Double-blind Treatment
Lack of analgesic effect
|
0
|
5
|
6
|
|
Double-blind Treatment
Non-compliance
|
0
|
5
|
4
|
|
Double-blind Treatment
Opioid withdrawal symptoms
|
0
|
0
|
1
|
|
Double-blind Treatment
Other
|
0
|
9
|
12
|
Baseline Characteristics
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
Baseline characteristics by cohort
| Measure |
DB Buprenorphine HCl Buccal Film
n=117 Participants
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
n=118 Participants
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
Total
n=235 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
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Continuous
|
52.0 years
n=5 Participants
|
51.5 years
n=7 Participants
|
52.0 years
n=5 Participants
|
|
Gender
Female
|
62 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Gender
Male
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
117 participants
n=5 Participants
|
118 participants
n=7 Participants
|
235 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Analysis based on Intent-to-Treat (ITT) population; all randomized subjects who received at least 1 dose of double-blind study medication.
Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Outcome measures
| Measure |
DB Buprenorphine HCl Buccal Film
n=117 Participants
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
n=118 Participants
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|
|
Change in Pain Intensity From Baseline to Week 12
|
0.33 units on a scale
Standard Deviation 1.944
|
0.46 units on a scale
Standard Deviation 2.093
|
SECONDARY outcome
Timeframe: Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84Population: Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.
Change in pain intensity = average of daily pain scores from the last 7 days prior to each visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Outcome measures
| Measure |
DB Buprenorphine HCl Buccal Film
n=117 Participants
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
n=118 Participants
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|
|
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Day 14
|
0.21 units on a scale
Standard Deviation 1.469
|
0.25 units on a scale
Standard Deviation 1.624
|
|
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Day 28
|
0.20 units on a scale
Standard Deviation 1.539
|
0.29 units on a scale
Standard Deviation 1.877
|
|
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Day 42
|
0.13 units on a scale
Standard Deviation 1.535
|
0.25 units on a scale
Standard Deviation 1.840
|
|
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Day 56
|
0.21 units on a scale
Standard Deviation 1.709
|
0.23 units on a scale
Standard Deviation 1.926
|
|
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Day 70
|
0.15 units on a scale
Standard Deviation 1.783
|
0.35 units on a scale
Standard Deviation 2.056
|
|
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Day 84
|
0.29 units on a scale
Standard Deviation 1.984
|
0.38 units on a scale
Standard Deviation 2.058
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.
Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Outcome measures
| Measure |
DB Buprenorphine HCl Buccal Film
n=117 Participants
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
n=118 Participants
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
≥90% Response
|
5 participants
|
7 participants
|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
≥0% Response
|
117 participants
|
118 participants
|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
≥10% Response
|
48 participants
|
32 participants
|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
≥20% Response
|
37 participants
|
30 participants
|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
≥30% Response
|
28 participants
|
27 participants
|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
≥40% Response
|
19 participants
|
23 participants
|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
≥50% Response
|
13 participants
|
20 participants
|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
≥60% Response
|
11 participants
|
16 participants
|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
≥70% Response
|
8 participants
|
13 participants
|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
≥80% Response
|
5 participants
|
9 participants
|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
≥100% Response
|
3 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)Population: Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.
Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.
Outcome measures
| Measure |
DB Buprenorphine HCl Buccal Film
n=117 Participants
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
n=118 Participants
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|
|
Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
|
9.4 percentage of participants
|
11.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.
Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).
Outcome measures
| Measure |
DB Buprenorphine HCl Buccal Film
n=117 Participants
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
n=118 Participants
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|
|
Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
|
-0.32 units on a scale
Standard Deviation 2.091
|
-0.92 units on a scale
Standard Deviation 2.110
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).
Outcome measures
| Measure |
DB Buprenorphine HCl Buccal Film
n=117 Participants
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
n=118 Participants
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|
|
Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
Effectiveness
|
-2.06 units on a scale
Standard Deviation 25.172
|
-9.03 units on a scale
Standard Deviation 27.804
|
|
Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
Side effects
|
3.09 units on a scale
Standard Deviation 14.137
|
10.88 units on a scale
Standard Deviation 18.243
|
|
Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
Convenience
|
-3.12 units on a scale
Standard Deviation 13.294
|
-0.00 units on a scale
Standard Deviation 14.081
|
|
Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
Global satisfaction
|
-8.19 units on a scale
Standard Deviation 26.146
|
-11.73 units on a scale
Standard Deviation 26.829
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication
Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.
Outcome measures
| Measure |
DB Buprenorphine HCl Buccal Film
n=117 Participants
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
n=118 Participants
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|
|
Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
|
0.09 units on a scale
Standard Deviation 5.606
|
1.00 units on a scale
Standard Deviation 4.319
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.
Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).
Outcome measures
| Measure |
DB Buprenorphine HCl Buccal Film
n=117 Participants
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
n=118 Participants
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|
|
Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug
|
-0.30 units on a scale
Standard Deviation 1.409
|
-0.48 units on a scale
Standard Deviation 1.329
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.
Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).
Outcome measures
| Measure |
DB Buprenorphine HCl Buccal Film
n=117 Participants
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
n=118 Participants
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|
|
Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
|
-0.27 units on a scale
Standard Deviation 1.312
|
-0.37 units on a scale
Standard Deviation 1.369
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phasePopulation: Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication
Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.
Outcome measures
| Measure |
DB Buprenorphine HCl Buccal Film
n=117 Participants
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
DB Placebo Film
n=118 Participants
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
|
|---|---|---|
|
Use of Rescue Medication
Day 7
|
0.87 Tablets per day
Standard Deviation 1.143
|
0.82 Tablets per day
Standard Deviation 1.103
|
|
Use of Rescue Medication
Day 14
|
0.93 Tablets per day
Standard Deviation 1.135
|
1.03 Tablets per day
Standard Deviation 1.289
|
|
Use of Rescue Medication
Day 28
|
0.93 Tablets per day
Standard Deviation 1.239
|
1.02 Tablets per day
Standard Deviation 1.325
|
|
Use of Rescue Medication
Day 42
|
0.97 Tablets per day
Standard Deviation 1.250
|
1.04 Tablets per day
Standard Deviation 1.358
|
|
Use of Rescue Medication
Day 56
|
0.89 Tablets per day
Standard Deviation 1.245
|
0.99 Tablets per day
Standard Deviation 1.364
|
|
Use of Rescue Medication
Day 70
|
0.83 Tablets per day
Standard Deviation 1.197
|
0.98 Tablets per day
Standard Deviation 1.611
|
|
Use of Rescue Medication
Day 84
|
0.97 Tablets per day
Standard Deviation 1.277
|
0.91 Tablets per day
Standard Deviation 1.276
|
|
Use of Rescue Medication
Follow-up Day 91
|
0.79 Tablets per day
Standard Deviation 1.143
|
1.07 Tablets per day
Standard Deviation 1.370
|
Adverse Events
OL Buprenorphine HCl Buccal Film
Serious events: 1 serious events
Other events: 163 other events
Deaths: 0 deaths
DB Buprenorphine HCl Buccal Film
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
DB Placebo Film
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OL Buprenorphine HCl Buccal Film
n=330 participants at risk
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
|
DB Buprenorphine HCl Buccal Film
n=117 participants at risk
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
|
DB Placebo Film
n=118 participants at risk
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
|
|---|---|---|---|
|
Infections and infestations
PNEUMONIA
|
0.30%
1/330 • Number of events 1 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
0.00%
0/117 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
0.00%
0/118 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.30%
1/330 • Number of events 1 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
0.00%
0/117 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
0.00%
0/118 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/330 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
0.85%
1/117 • Number of events 1 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
0.00%
0/118 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.30%
1/330 • Number of events 1 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
0.00%
0/117 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
0.00%
0/118 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
Other adverse events
| Measure |
OL Buprenorphine HCl Buccal Film
n=330 participants at risk
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
|
DB Buprenorphine HCl Buccal Film
n=117 participants at risk
Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
|
DB Placebo Film
n=118 participants at risk
Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
|
|---|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
10.9%
36/330 • Number of events 37 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
6.0%
7/117 • Number of events 7 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
2.5%
3/118 • Number of events 4 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
|
Gastrointestinal disorders
NAUSEA
|
32.7%
108/330 • Number of events 118 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
9.4%
11/117 • Number of events 11 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
8.5%
10/118 • Number of events 11 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
|
Gastrointestinal disorders
VOMITING
|
5.8%
19/330 • Number of events 19 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
5.1%
6/117 • Number of events 7 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
3.4%
4/118 • Number of events 4 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.1%
7/330 • Number of events 7 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
2.6%
3/117 • Number of events 3 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
5.9%
7/118 • Number of events 7 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
|
Nervous system disorders
DIZZINESS
|
9.1%
30/330 • Number of events 35 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
3.4%
4/117 • Number of events 4 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
0.85%
1/118 • Number of events 1 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
|
Nervous system disorders
HEADACHE
|
11.8%
39/330 • Number of events 45 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
10.3%
12/117 • Number of events 14 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
4.2%
5/118 • Number of events 6 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
|
Psychiatric disorders
INSOMNIA
|
2.4%
8/330 • Number of events 9 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
6.0%
7/117 • Number of events 7 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
2.5%
3/118 • Number of events 3 • From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks
Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The oral or written use of study results by the Investigator is not permitted without the express written consent from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER