Trial Outcomes & Findings for Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain (NCT NCT00387010)
NCT ID: NCT00387010
Last Updated: 2012-10-22
Results Overview
The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.
TERMINATED
PHASE3
218 participants
Day 0 (baseline), approximately week 5
2012-10-22
Participant Flow
A total of 327 patients with chronic pain and breakthrough pain (BTP) were screened for enrollment into this study. Of the 327 patients screened, 218 patients at 31 centers in the US met entry criteria and were considered eligible for enrollment into the study.
Participant milestones
| Measure |
Fentanyl Buccal Tablets
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Dose Titration Period
STARTED
|
218
|
|
Dose Titration Period
COMPLETED
|
180
|
|
Dose Titration Period
NOT COMPLETED
|
38
|
|
Treatment Period
STARTED
|
180
|
|
Treatment Period
Full Analysis Set
|
175
|
|
Treatment Period
COMPLETED
|
169
|
|
Treatment Period
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Fentanyl Buccal Tablets
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Dose Titration Period
Adverse Event
|
12
|
|
Dose Titration Period
Lack of Efficacy
|
5
|
|
Dose Titration Period
Withdrawal by Subject
|
3
|
|
Dose Titration Period
Protocol Violation
|
1
|
|
Dose Titration Period
Lost to Follow-up
|
2
|
|
Dose Titration Period
Noncompliance with study medication
|
8
|
|
Dose Titration Period
Noncompliance with study procedures
|
7
|
|
Treatment Period
Adverse Event
|
4
|
|
Treatment Period
Withdrawal by Subject
|
1
|
|
Treatment Period
Noncompliance with study medication
|
2
|
|
Treatment Period
Noncompliance with study procedures
|
3
|
|
Treatment Period
Participant reported study drug stolen
|
1
|
Baseline Characteristics
Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain
Baseline characteristics by cohort
| Measure |
Fentanyl Buccal Tablets
n=218 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Age Continuous
|
49.9 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
203 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
208 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 participants
n=5 Participants
|
|
Primary chronic painful condition
Back pain
|
136 participants
n=5 Participants
|
|
Primary chronic painful condition
Neck pain
|
14 participants
n=5 Participants
|
|
Primary chronic painful condition
Fibromyalgia
|
13 participants
n=5 Participants
|
|
Primary chronic painful condition
Traumatic injury
|
12 participants
n=5 Participants
|
|
Primary chronic painful condition
Osteoarthritis
|
11 participants
n=5 Participants
|
|
Primary chronic painful condition
Complex regional pain syndrome
|
9 participants
n=5 Participants
|
|
Primary chronic painful condition
Diabetic peripheral neuropathy
|
3 participants
n=5 Participants
|
|
Primary chronic painful condition
Cancer
|
3 participants
n=5 Participants
|
|
Primary chronic painful condition
Chronic pancreatitis
|
2 participants
n=5 Participants
|
|
Primary chronic painful condition
Other
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (baseline), approximately week 5Population: Full analysis set
The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=175 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5
|
-1.6 units on a scale
Standard Deviation 20.71
|
SECONDARY outcome
Timeframe: Day 0 (baseline), approximately week 5Population: Full analysis set
The change from baseline to approximately week 5 in the PASS subscale scores. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. Those 40 questions are organized into four subscales: fear, cognitive anxiety, somatic anxiety, and escape/avoidance. Each subscale score is obtained by summing the answers to the ten items in the subscore resulting in a range of 0-50.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=175 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5
Fear
|
-0.5 units on a scale
Standard Deviation 6.14
|
|
Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5
Cognitive anxiety
|
-1.1 units on a scale
Standard Deviation 7.20
|
|
Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5
Somatic anxiety
|
0.4 units on a scale
Standard Deviation 7.39
|
|
Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5
Escape/avoidance
|
-0.4 units on a scale
Standard Deviation 5.87
|
SECONDARY outcome
Timeframe: Day 0 (baseline), approximately week 5Population: Full analysis set of participants who answered the questions.
Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Beck Depression Inventory (BDI). The BDI is a self-reporting instrument that asks 21 questions regarding how the participant felt in the past few days. Answers are in sentence form, and offer a scale where the first answer (worth 0 points) indicates no depression and the fourth answer (worth 3 points) indicates significant depression. Totals (0-63) are grouped so that totals of 1-10 are interpreted as 'These ups and downs are considered normal' and scores \>40 indicate extreme depression.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=169 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Change From Baseline in the Beck Depression Inventory at Approximately Week 5
|
-1.1 units on a scale
Standard Deviation 6.98
|
SECONDARY outcome
Timeframe: Day 0 (baseline), approximately week 5Population: Full analysis set
Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Multidimensional Pain Inventory Subscales. Answers to questions in the MPI are captured on a 7-point scale, with 0=most positive answer and 6= least positive answer. Twenty questions focus on pain, fourteen on a significant other's response when participant is in pain, and eighteen questions about daily activities. There are a total of 13 subscales with variable ranges. Subscales and corresponding ranges are listed in the results table. The General Activity category combines the Household Chores, Outdoor Work, Activities Away from Home, and Social Activities categories.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=175 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Interference (0-54)
|
-0.2 units on a scale
Standard Deviation 0.90
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Support (0-18)
|
-0.0 units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Pain Severity (0-18)
|
-0.3 units on a scale
Standard Deviation 0.97
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Life-Control (0-12)
|
0.1 units on a scale
Standard Deviation 1.25
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Affective Distress (0-18)
|
-0.1 units on a scale
Standard Deviation 1.24
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Negative Responses (0-24)
|
-0.1 units on a scale
Standard Deviation 1.01
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Solicitous Responses (0-24)
|
0.1 units on a scale
Standard Deviation 1.03
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Distracting Responses (0-36)
|
0.2 units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Household Chores (0-30)
|
0.1 units on a scale
Standard Deviation 1.05
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Outdoor Work (0-30)
|
-0.0 units on a scale
Standard Deviation 0.74
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Activities Away from Home (0-24)
|
0.1 units on a scale
Standard Deviation 0.87
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Social Activities (0-24)
|
0.0 units on a scale
Standard Deviation 0.86
|
|
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
General Activity (0-108)
|
0.0 units on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set of participants who answered the questions.
The summary question from the Pain Flare Treatment Satisfaction Questionnaire asked participants which medication they preferred to use for their break-through pain. Options were 1) Prior medication 2) Study medication 3) no preference
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=174 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Medication Preference From the Pain Flare Treatment Satisfaction Questionnaire at Approximately Week 5
Prior medication
|
38 participants
|
|
Medication Preference From the Pain Flare Treatment Satisfaction Questionnaire at Approximately Week 5
Study medication
|
115 participants
|
|
Medication Preference From the Pain Flare Treatment Satisfaction Questionnaire at Approximately Week 5
No preference
|
21 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set of participants who answered the question
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to go to work.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=88 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Patient Assessment of Ability to Go to Work at Approximately Week 5
Very much worsened
|
2 participants
|
|
Patient Assessment of Ability to Go to Work at Approximately Week 5
Much worsened
|
0 participants
|
|
Patient Assessment of Ability to Go to Work at Approximately Week 5
Slightly worsened
|
2 participants
|
|
Patient Assessment of Ability to Go to Work at Approximately Week 5
Unchanged
|
51 participants
|
|
Patient Assessment of Ability to Go to Work at Approximately Week 5
Slightly improved
|
14 participants
|
|
Patient Assessment of Ability to Go to Work at Approximately Week 5
Much improved
|
13 participants
|
|
Patient Assessment of Ability to Go to Work at Approximately Week 5
Very much improved
|
6 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set of participants who answered the question
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to perform at work and includes both work outside the home and housework.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=175 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Patient Assessment of Ability to Perform at Work at Approximately Week 5
Very much worsened
|
4 participants
|
|
Patient Assessment of Ability to Perform at Work at Approximately Week 5
Much worsened
|
1 participants
|
|
Patient Assessment of Ability to Perform at Work at Approximately Week 5
Slightly worsened
|
6 participants
|
|
Patient Assessment of Ability to Perform at Work at Approximately Week 5
Unchanged
|
69 participants
|
|
Patient Assessment of Ability to Perform at Work at Approximately Week 5
Slightly improved
|
41 participants
|
|
Patient Assessment of Ability to Perform at Work at Approximately Week 5
Much improved
|
45 participants
|
|
Patient Assessment of Ability to Perform at Work at Approximately Week 5
Very much improved
|
9 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set of participants who answered the question
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to walk.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=174 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Patient Assessment of Ability to Walk at Approximately Week 5
Very much improved
|
11 participants
|
|
Patient Assessment of Ability to Walk at Approximately Week 5
Very much worsened
|
3 participants
|
|
Patient Assessment of Ability to Walk at Approximately Week 5
Much worsened
|
1 participants
|
|
Patient Assessment of Ability to Walk at Approximately Week 5
Slightly worsened
|
5 participants
|
|
Patient Assessment of Ability to Walk at Approximately Week 5
Unchanged
|
76 participants
|
|
Patient Assessment of Ability to Walk at Approximately Week 5
Slightly improved
|
42 participants
|
|
Patient Assessment of Ability to Walk at Approximately Week 5
Much improved
|
36 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set of participants who answered the question
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to exercise.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=175 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Patient Assessment of Ability to Exercise at Approximately Week 5
Very much worsened
|
3 participants
|
|
Patient Assessment of Ability to Exercise at Approximately Week 5
Much worsened
|
1 participants
|
|
Patient Assessment of Ability to Exercise at Approximately Week 5
Slightly worsened
|
5 participants
|
|
Patient Assessment of Ability to Exercise at Approximately Week 5
Unchanged
|
90 participants
|
|
Patient Assessment of Ability to Exercise at Approximately Week 5
Slightly improved
|
46 participants
|
|
Patient Assessment of Ability to Exercise at Approximately Week 5
Much improved
|
21 participants
|
|
Patient Assessment of Ability to Exercise at Approximately Week 5
Very much improved
|
9 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set of participants who answered the question
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to participate in social events.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=175 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Patient Assessment of Ability to Participate in Social Events at Approximately Week 5
Very much worsened
|
1 participants
|
|
Patient Assessment of Ability to Participate in Social Events at Approximately Week 5
Much worsened
|
3 participants
|
|
Patient Assessment of Ability to Participate in Social Events at Approximately Week 5
Slightly worsened
|
6 participants
|
|
Patient Assessment of Ability to Participate in Social Events at Approximately Week 5
Unchanged
|
80 participants
|
|
Patient Assessment of Ability to Participate in Social Events at Approximately Week 5
Slightly improved
|
46 participants
|
|
Patient Assessment of Ability to Participate in Social Events at Approximately Week 5
Much improved
|
34 participants
|
|
Patient Assessment of Ability to Participate in Social Events at Approximately Week 5
Very much improved
|
5 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set of participants who answered the question
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to have sex.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=173 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Patient Assessment of Ability to Have Sex at Approximately Week 5
Much improved
|
12 participants
|
|
Patient Assessment of Ability to Have Sex at Approximately Week 5
Very much worsened
|
4 participants
|
|
Patient Assessment of Ability to Have Sex at Approximately Week 5
Much worsened
|
2 participants
|
|
Patient Assessment of Ability to Have Sex at Approximately Week 5
Slightly worsened
|
3 participants
|
|
Patient Assessment of Ability to Have Sex at Approximately Week 5
Unchanged
|
129 participants
|
|
Patient Assessment of Ability to Have Sex at Approximately Week 5
Slightly improved
|
18 participants
|
|
Patient Assessment of Ability to Have Sex at Approximately Week 5
Very much improved
|
5 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set of participants who answered the question
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to enjoy life.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=175 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Patient Assessment of Ability to Enjoy Life at Approximately Week 5
Very much worsened
|
2 participants
|
|
Patient Assessment of Ability to Enjoy Life at Approximately Week 5
Much worsened
|
1 participants
|
|
Patient Assessment of Ability to Enjoy Life at Approximately Week 5
Slightly worsened
|
6 participants
|
|
Patient Assessment of Ability to Enjoy Life at Approximately Week 5
Unchanged
|
66 participants
|
|
Patient Assessment of Ability to Enjoy Life at Approximately Week 5
Slightly improved
|
48 participants
|
|
Patient Assessment of Ability to Enjoy Life at Approximately Week 5
Much improved
|
38 participants
|
|
Patient Assessment of Ability to Enjoy Life at Approximately Week 5
Very much improved
|
14 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's general activities.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=175 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Clinical Assessment of Patient Function - General Activities - at Approximately Week 5
Very much worsened
|
0 participants
|
|
Clinical Assessment of Patient Function - General Activities - at Approximately Week 5
Much worsened
|
1 participants
|
|
Clinical Assessment of Patient Function - General Activities - at Approximately Week 5
Slightly worsened
|
4 participants
|
|
Clinical Assessment of Patient Function - General Activities - at Approximately Week 5
Unchanged
|
58 participants
|
|
Clinical Assessment of Patient Function - General Activities - at Approximately Week 5
Slightly improved
|
57 participants
|
|
Clinical Assessment of Patient Function - General Activities - at Approximately Week 5
Much improved
|
46 participants
|
|
Clinical Assessment of Patient Function - General Activities - at Approximately Week 5
Very much improved
|
9 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set. One participant was not assessed by the investigator.
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's walking ability.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=174 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5
Very much improved
|
10 participants
|
|
Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5
Very much worsened
|
0 participants
|
|
Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5
Much worsened
|
0 participants
|
|
Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5
Slightly worsened
|
4 participants
|
|
Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5
Unchanged
|
81 participants
|
|
Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5
Slightly improved
|
48 participants
|
|
Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5
Much improved
|
31 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's ability to work and perform activities of daily living.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=175 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5
Very much worsened
|
0 participants
|
|
Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5
Much worsened
|
1 participants
|
|
Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5
Slightly worsened
|
5 participants
|
|
Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5
Unchanged
|
63 participants
|
|
Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5
Slightly improved
|
55 participants
|
|
Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5
Much improved
|
39 participants
|
|
Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5
Very much improved
|
12 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's relationship with others.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=175 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5
Very much worsened
|
0 participants
|
|
Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5
Much worsened
|
0 participants
|
|
Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5
Slightly worsened
|
1 participants
|
|
Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5
Unchanged
|
98 participants
|
|
Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5
Slightly improved
|
35 participants
|
|
Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5
Much improved
|
32 participants
|
|
Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5
Very much improved
|
9 participants
|
SECONDARY outcome
Timeframe: approximately week 5Population: Full analysis set
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's enjoyment of life.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=175 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5
Very much worsened
|
0 participants
|
|
Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5
Much worsened
|
2 participants
|
|
Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5
Slightly worsened
|
1 participants
|
|
Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5
Unchanged
|
69 participants
|
|
Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5
Slightly improved
|
45 participants
|
|
Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5
Much improved
|
43 participants
|
|
Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5
Very much improved
|
15 participants
|
SECONDARY outcome
Timeframe: up to 10 daysPopulation: Safety analysis set
During the dose titration period, participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg if needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated. This outcome summarizes the successful dose levels identified during the titration period.
Outcome measures
| Measure |
Fentanyl Buccal Tablets
n=218 Participants
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)
100 mcg
|
18 participants
|
|
Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)
200 mcg
|
49 participants
|
|
Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)
400 mcg
|
41 participants
|
|
Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)
600 mcg
|
31 participants
|
|
Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)
800 mcg
|
41 participants
|
|
Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)
None (no successful dose)
|
38 participants
|
Adverse Events
Fentanyl Buccal Tablets
Serious adverse events
| Measure |
Fentanyl Buccal Tablets
n=218 participants at risk
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Infections and infestations
Bronchitis
|
0.46%
1/218 • Treatment emergent adverse events: Day 1 to approximately 5 weeks.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.46%
1/218 • Treatment emergent adverse events: Day 1 to approximately 5 weeks.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.46%
1/218 • Treatment emergent adverse events: Day 1 to approximately 5 weeks.
|
|
Psychiatric disorders
Suicide attempt
|
0.46%
1/218 • Treatment emergent adverse events: Day 1 to approximately 5 weeks.
|
Other adverse events
| Measure |
Fentanyl Buccal Tablets
n=218 participants at risk
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
9.6%
21/218 • Treatment emergent adverse events: Day 1 to approximately 5 weeks.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
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