Trial Outcomes & Findings for Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients (NCT NCT00842829)
NCT ID: NCT00842829
Last Updated: 2012-10-01
Results Overview
The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
330 participants
Primary outcome timeframe
Day 1 up to Day 7
Results posted on
2012-10-01
Participant Flow
A total of 442 patients already receiving opioid maintenance therapy for chronic cancer pain and experiencing up to 4 BTP episodes per 24 hours (on average) were screened at 135 centers in 7 European countries.
Participant milestones
| Measure |
FBT 100 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment and Continuation Periods
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days). The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|
|
Dose Titration Period
STARTED
|
156
|
174
|
0
|
|
Dose Titration Period
Titration Safety Analysis Set
|
145
|
167
|
0
|
|
Dose Titration Period
COMPLETED
|
130
|
151
|
0
|
|
Dose Titration Period
NOT COMPLETED
|
26
|
23
|
0
|
|
Treatment Period
STARTED
|
0
|
0
|
281
|
|
Treatment Period
Safety Analysis Set
|
0
|
0
|
223
|
|
Treatment Period
COMPLETED
|
0
|
0
|
218
|
|
Treatment Period
NOT COMPLETED
|
0
|
0
|
63
|
|
Continuation Period
STARTED
|
0
|
0
|
88
|
|
Continuation Period
Continuation Safety Analysis Set
|
0
|
0
|
87
|
|
Continuation Period
COMPLETED
|
0
|
0
|
27
|
|
Continuation Period
NOT COMPLETED
|
0
|
0
|
61
|
Reasons for withdrawal
| Measure |
FBT 100 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment and Continuation Periods
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days). The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|
|
Dose Titration Period
Adverse Event
|
11
|
10
|
0
|
|
Dose Titration Period
Lack of Efficacy
|
4
|
1
|
0
|
|
Dose Titration Period
Unstable persistent cancer pain
|
1
|
0
|
0
|
|
Dose Titration Period
Withdrawal by Subject
|
2
|
6
|
0
|
|
Dose Titration Period
Other
|
5
|
4
|
0
|
|
Dose Titration Period
Non-compliance to study procedures
|
1
|
1
|
0
|
|
Dose Titration Period
Non-compliance to study drug
|
2
|
1
|
0
|
|
Treatment Period
Adverse Event
|
0
|
0
|
15
|
|
Treatment Period
Lack of Efficacy
|
0
|
0
|
6
|
|
Treatment Period
Unstable persistent cancer pain
|
0
|
0
|
5
|
|
Treatment Period
Withdrawal by Subject
|
0
|
0
|
11
|
|
Treatment Period
Consistently >4 BTP episodes daily
|
0
|
0
|
1
|
|
Treatment Period
Protocol Violation
|
0
|
0
|
2
|
|
Treatment Period
Other
|
0
|
0
|
18
|
|
Treatment Period
Non-compliance to study procedures
|
0
|
0
|
4
|
|
Treatment Period
Unclear completion status
|
0
|
0
|
1
|
|
Continuation Period
Adverse Event
|
0
|
0
|
32
|
|
Continuation Period
Lack of Efficacy
|
0
|
0
|
6
|
|
Continuation Period
Unstable persistent cancer pain
|
0
|
0
|
3
|
|
Continuation Period
Withdrawal by Subject
|
0
|
0
|
10
|
|
Continuation Period
Other
|
0
|
0
|
7
|
|
Continuation Period
Non-compliance to study procedures
|
0
|
0
|
2
|
|
Continuation Period
Non-compliance to study drug
|
0
|
0
|
1
|
Baseline Characteristics
Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
Baseline characteristics by cohort
| Measure |
FBT 100 Mcg - Dose Titration Period
n=156 Participants
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT 200 Mcg - Dose Titration Period
n=174 Participants
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.5 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 10.97 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 11.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
16 participants
n=5 Participants
|
25 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
38 participants
n=5 Participants
|
41 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
32 participants
n=5 Participants
|
38 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Cancer Site
Breast
|
31 participants
n=5 Participants
|
36 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Cancer Site
Colon/rectum
|
15 participants
n=5 Participants
|
25 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Cancer Site
Colon/rectum + Pancreas/stomach + other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Cancer Site
Head/neck
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Cancer Site
Leukemia/lymphoma
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Cancer Site
Myeloma
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Cancer Site
Oesophageal
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Cancer Site
Pancreas/stomach
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Cancer Site
Prostate
|
8 participants
n=5 Participants
|
17 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Cancer Site
Lung
|
26 participants
n=5 Participants
|
21 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Cancer Site
Other (not specified)
|
39 participants
n=5 Participants
|
42 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 7Population: Titration safety analysis set consisting of participants who took at least one dose of study medication.
The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes.
Outcome measures
| Measure |
FBT - Treatment Period
n=145 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
n=167 Participants
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period
|
75.2 percentage of treated participants
|
81.2 percentage of treated participants
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 8-15Population: Safety analysis set consisting of participants who received at least one dose of study drug during the Treatment Period, and who recorded the time to pain relief in the patient diary.
Overall episode data analyzed all values of time to meaningful pain relief taken over all BTP episodes during the treatment period. If meaningful pain relief was not achieved within 60 minutes of FBT intake, or if rescue medication was taken, the event was censored. Meaningful pain relief was left to the judgment of participants, who used a stopwatch and recorded the time from treatment until pain relief in a patient diary.
Outcome measures
| Measure |
FBT - Treatment Period
n=1810 breakthrough pain episodes
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Kaplan-Meier Estimates for Time to Meaningful Pain Relief As Assessed by Participants During the Treatment Period For Overall Breakthrough Pain (BTP) Episodes
|
19.00 minutes
Interval 12.0 to 30.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 7Population: Titration safety analysis set consisting of participants who took at least one dose of study medication.
Number of participants for which an effective dose of FBT was reached as judged by each participant. The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes.
Outcome measures
| Measure |
FBT - Treatment Period
n=145 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
n=167 Participants
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period
100 mcg
|
34 participants
|
7 participants
|
—
|
—
|
|
Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period
200 mcg
|
38 participants
|
61 participants
|
—
|
—
|
|
Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period
300 mcg (evaluated by mistake)
|
1 participants
|
1 participants
|
—
|
—
|
|
Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period
400 mcg
|
23 participants
|
42 participants
|
—
|
—
|
|
Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period
600 mcg
|
8 participants
|
15 participants
|
—
|
—
|
|
Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period
800 mcg
|
5 participants
|
10 participants
|
—
|
—
|
|
Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period
Missing
|
36 participants
|
31 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 to up to Day 7 (Titration Period); approximately Day 8 up to Day 15 (Treatment Period)Population: Safety analysis set consisting of participants who took at least one dose of study drug during the relevant study period.
The number of breakthrough pain (BTP) episodes in which the participant did not obtain effective pain relief from study medication and took a rescue medication.
Outcome measures
| Measure |
FBT - Treatment Period
n=2610 breakthrough pain episodes
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
n=1810 breakthrough pain episodes
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Breakthrough Pain (BTP) Episodes Requiring the Use of Rescue Medication During the Titration Period and the Treatment Period
|
102 BTP episodes
|
153 BTP episodes
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 8-15Population: Safety analysis set of participants with a response at the time point (30 or 60 minutes) post dose.
Participants assessed the performance of FBT at 30 minutes and 60 minutes after dosing each episode during the treatment period. For each episode, the participant answered the question 'How well did your study medication perform in controlling the breakthrough pain episode?' on a 5-point Likert-type scale (poor=0, fair=1, good=2, very good=3, and excellent=4).
Outcome measures
| Measure |
FBT - Treatment Period
n=1776 breakthrough pain episodes
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
n=1668 breakthrough pain episodes
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participant Assessment of Medication Performance During the Treatment Period
Good
|
712 BTP episodes
|
646 BTP episodes
|
—
|
—
|
|
Participant Assessment of Medication Performance During the Treatment Period
Excellent
|
103 BTP episodes
|
144 BTP episodes
|
—
|
—
|
|
Participant Assessment of Medication Performance During the Treatment Period
Very good
|
433 BTP episodes
|
584 BTP episodes
|
—
|
—
|
|
Participant Assessment of Medication Performance During the Treatment Period
Fair
|
428 BTP episodes
|
245 BTP episodes
|
—
|
—
|
|
Participant Assessment of Medication Performance During the Treatment Period
Poor
|
100 BTP episodes
|
49 BTP episodes
|
—
|
—
|
|
Participant Assessment of Medication Performance During the Treatment Period
Missing
|
35 BTP episodes
|
143 BTP episodes
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline), approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with both baseline and Treatment Period responses
Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses general activity.
Outcome measures
| Measure |
FBT - Treatment Period
n=206 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: General Activity
|
-1.0 units on a scale
Standard Deviation 2.52
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline), approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with both baseline and Treatment Period responses
Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses mood.
Outcome measures
| Measure |
FBT - Treatment Period
n=205 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Mood
|
-1.4 units on a scale
Standard Deviation 2.55
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline), approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with both baseline and Treatment Period responses
Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses walking ability.
Outcome measures
| Measure |
FBT - Treatment Period
n=201 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Walking Ability
|
-0.9 units on a scale
Standard Deviation 2.29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline), approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with both baseline and Treatment Period responses
Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses normal work.
Outcome measures
| Measure |
FBT - Treatment Period
n=200 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Normal Work
|
-1.3 units on a scale
Standard Deviation 2.61
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline), approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with both baseline and Treatment Period responses
Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses relations with other people.
Outcome measures
| Measure |
FBT - Treatment Period
n=205 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Relations With Other People
|
-1.2 units on a scale
Standard Deviation 2.50
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline), approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with both baseline and Treatment Period responses
Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses sleep.
Outcome measures
| Measure |
FBT - Treatment Period
n=204 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Sleep
|
-1.4 units on a scale
Standard Deviation 2.66
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline), approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with both baseline and Treatment Period responses
Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses enjoyment of life.
Outcome measures
| Measure |
FBT - Treatment Period
n=204 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Enjoyment of Life
|
-1.5 units on a scale
Standard Deviation 2.77
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline), approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with both baseline and Treatment Period responses
Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. The Global Score is the sum of the subscales (total scale is 0-70). A negative change from baseline represents an improvement.
Outcome measures
| Measure |
FBT - Treatment Period
n=198 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire: Global Score
|
-8.6 units on a scale
Standard Deviation 13.47
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with a response
Responses to the Patient Satisfaction questionnaire question, "Satisfied with the BTP Treatment?", were captured on a five-point scale from 0=not at all to 4=very much.
Outcome measures
| Measure |
FBT - Treatment Period
n=203 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period
Very much
|
64 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period
Quite a bit
|
92 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period
Somewhat
|
37 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period
A little bit
|
8 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period
Not at all
|
2 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with a response
Responses to the Patient Satisfaction questionnaire question, "Does this BTP medication relieve your pain quickly so you can get back to sleep?", were captured on a five-point scale from 0=not at all to 4=very much.
Outcome measures
| Measure |
FBT - Treatment Period
n=202 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participant's Global Assessment of Satisfaction (Does This BTP Medication Relieve Your Pain Quickly so You Can Get Back to Sleep?) at the End of the Treatment Period
Very much
|
55 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This BTP Medication Relieve Your Pain Quickly so You Can Get Back to Sleep?) at the End of the Treatment Period
Quite a bit
|
104 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This BTP Medication Relieve Your Pain Quickly so You Can Get Back to Sleep?) at the End of the Treatment Period
Somewhat
|
27 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This BTP Medication Relieve Your Pain Quickly so You Can Get Back to Sleep?) at the End of the Treatment Period
A little bit
|
13 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This BTP Medication Relieve Your Pain Quickly so You Can Get Back to Sleep?) at the End of the Treatment Period
Not at all
|
3 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with a response
Responses to the Patient Satisfaction questionnaire question, "Does this medication work fast?", were captured on a five-point scale from 0=not at all to 4=very much.
Outcome measures
| Measure |
FBT - Treatment Period
n=203 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period
Very much
|
63 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period
Quite a bit
|
88 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period
Somewhat
|
36 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period
A little bit
|
12 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period
Not at all
|
4 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with a response
Responses to the Patient Satisfaction questionnaire question, "Does this medication provide adequate relief?", were captured on a five-point scale from 0=not at all to 4=very much.
Outcome measures
| Measure |
FBT - Treatment Period
n=203 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period
Very much
|
57 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period
Quite a bit
|
104 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period
Somewhat
|
35 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period
A little bit
|
5 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period
Not at all
|
2 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with a response
Responses to the Patient Satisfaction questionnaire question, "Is this medication easy to take?", were captured on a five-point scale from 0=not at all to 4=very much.
Outcome measures
| Measure |
FBT - Treatment Period
n=203 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period
Very much
|
81 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period
Quite a bit
|
74 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period
Somewhat
|
31 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period
A little bit
|
9 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period
Not at all
|
8 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with a response
Responses to the Patient Satisfaction questionnaire question, "Do you find this medication comfortable to take in public?", were captured on a five-point scale from 0=not at all to 4=very much.
Outcome measures
| Measure |
FBT - Treatment Period
n=203 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period
Very much
|
81 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period
Quite a bit
|
78 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period
Somewhat
|
26 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period
A little bit
|
10 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period
Not at all
|
8 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with a response
Responses to the Patient Satisfaction questionnaire question, "Do you feel safe taking this medication?", were captured on a five-point scale from 0=not at all to 4=very much.
Outcome measures
| Measure |
FBT - Treatment Period
n=203 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period
A little bit
|
2 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period
Not at all
|
0 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period
Very much
|
96 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period
Quite a bit
|
88 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period
Somewhat
|
17 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with a response
Responses to the Patient Satisfaction questionnaire question, "Do you understand the instructions?", were captured on a five-point scale from 0=not at all to 4=very much.
Outcome measures
| Measure |
FBT - Treatment Period
n=203 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period
Very much
|
107 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period
Quite a bit
|
81 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period
Somewhat
|
13 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period
A little bit
|
2 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period
Not at all
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with a response
Ease of use was assessed using the question 'Did you find this treatment easy/convenient to use for treatment of your breakthrough pain episodes?'. The answer was based on a 4-point numerical scale (0=Poor, 1=Fair, 2=Easy, 3=Very Easy). This assessment was performed at the end of the Treatment Period (or early termination).
Outcome measures
| Measure |
FBT - Treatment Period
n=209 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participant's Global Assessment of Ease of Use at the End of the Treatment Period
Very easy
|
67 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Ease of Use at the End of the Treatment Period
Easy
|
107 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Ease of Use at the End of the Treatment Period
Fair
|
28 participants
|
—
|
—
|
—
|
|
Participant's Global Assessment of Ease of Use at the End of the Treatment Period
Poor
|
7 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately Day 15 (end of Treatment Period)Population: Safety analysis set of participants with a response
Global impression of change was assessed using the question 'Since the start of the study, my overall status is?'. The answer was based on a 7-point scale (1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse). This assessment was performed at the end of the Treatment Period (or early termination).
Outcome measures
| Measure |
FBT - Treatment Period
n=208 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participant's Global Impression of Change at the End of the Treatment Period
Very much improved
|
15 participants
|
—
|
—
|
—
|
|
Participant's Global Impression of Change at the End of the Treatment Period
Much improved
|
75 participants
|
—
|
—
|
—
|
|
Participant's Global Impression of Change at the End of the Treatment Period
Minimally improved
|
65 participants
|
—
|
—
|
—
|
|
Participant's Global Impression of Change at the End of the Treatment Period
No change
|
32 participants
|
—
|
—
|
—
|
|
Participant's Global Impression of Change at the End of the Treatment Period
Minimally worse
|
14 participants
|
—
|
—
|
—
|
|
Participant's Global Impression of Change at the End of the Treatment Period
Much worse
|
7 participants
|
—
|
—
|
—
|
|
Participant's Global Impression of Change at the End of the Treatment Period
Very much worse
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1-7 (Titration Period). Day 8-15 (Treatment Period), Days 16-688 (Continuation Period)Population: Safety analysis set
Participants with treatment-emergent adverse events are summarized by each treatment period. Relation to study drug was assessed by the investigator. The 'Any AE' category below includes serious adverse events.
Outcome measures
| Measure |
FBT - Treatment Period
n=145 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT 200 Mcg - Dose Titration Period
n=167 Participants
During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
|
FBT - Treatment Period
n=223 Participants
Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
|
FBT - Continuation Period
n=87 Participants
The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
|
|---|---|---|---|---|
|
Participants With Adverse Events (AE) Summarized by Treatment Period
Any AE
|
44 participants
|
74 participants
|
43 participants
|
72 participants
|
|
Participants With Adverse Events (AE) Summarized by Treatment Period
Any Serious AE
|
8 participants
|
12 participants
|
4 participants
|
37 participants
|
|
Participants With Adverse Events (AE) Summarized by Treatment Period
AE leading to discontinuation of study drug
|
11 participants
|
19 participants
|
0 participants
|
25 participants
|
|
Participants With Adverse Events (AE) Summarized by Treatment Period
AE with a fatal outcome
|
6 participants
|
4 participants
|
3 participants
|
29 participants
|
|
Participants With Adverse Events (AE) Summarized by Treatment Period
AE considered related to study drug
|
19 participants
|
35 participants
|
15 participants
|
14 participants
|
Adverse Events
FBT - All Doses and Study Periods
Serious events: 67 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FBT - All Doses and Study Periods
n=312 participants at risk
Participants took fentanyl buccal tables (FBT) with doses between 100-800 mcg
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.96%
3/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.64%
2/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Cardiac disorders
Tachyarrhythmia
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Cardiac disorders
Cardiac arrest
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Dysphagia
|
0.64%
2/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.64%
2/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Nausea
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
4/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Abdominal pain
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Flatulence
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Ileus
|
0.64%
2/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Oedema mouth
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Subileus
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Tongue oedema
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
General disorders
Asthenia
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
General disorders
Cyst
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
General disorders
Pain
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
General disorders
Pyrexia
|
0.96%
3/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
General disorders
Fatigue
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
General disorders
Feeling abnormal
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
General disorders
Oedema peripheral
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Hepatobiliary disorders
Cholangitis
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Hepatobiliary disorders
Jaundice
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Infections and infestations
Infected cyst
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Infections and infestations
Pneumonia
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Infections and infestations
Subcutaneous abscess
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Infections and infestations
Urinary tract infection
|
0.64%
2/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Metabolism and nutrition disorders
Cachexia
|
0.64%
2/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Metabolism and nutrition disorders
Dehydration
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.64%
2/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.64%
2/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
6.7%
21/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.64%
2/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Nervous system disorders
Paraparesis
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Nervous system disorders
Headache
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Nervous system disorders
Grand mal convulsion
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Nervous system disorders
Hemiparesis
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Renal and urinary disorders
Renal failure
|
1.6%
5/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Renal and urinary disorders
Urinary retention
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Renal and urinary disorders
Haematuria
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.64%
2/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.96%
3/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.96%
3/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Vascular disorders
Superior vena caval occlusion
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.32%
1/312 • Treatment-emergent AEs from Day 1 up to day 688
|
Other adverse events
| Measure |
FBT - All Doses and Study Periods
n=312 participants at risk
Participants took fentanyl buccal tables (FBT) with doses between 100-800 mcg
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
9.6%
30/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
23/312 • Treatment-emergent AEs from Day 1 up to day 688
|
|
Nervous system disorders
Somnolence
|
5.1%
16/312 • Treatment-emergent AEs from Day 1 up to day 688
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER