A Phase 4 interventional study of Fentanyl Buccal Tablet (FBT) in Cancer Pain and Breakthrough Pain, sponsored by Cephalon. Terminated at 123 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-01.
Sponsored by Cephalon (part of Teva Pharmaceutical Industries, Ltd.) · Phase 4 and Interventional
Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually titrated to an effective dose that provides adequate analgesia and minimizes undesirable effects. To reach the safest effective dose for the individual patient as soon as possible, the dose titration process is critical. The aim of this study, conducted under pragmatic conditions in a large-scale population of cancer patients is to compare the proportion of patients reaching an effective FBT dose after titration starting with either a 100 mcg dose or a 200 mcg dose.
310 studies on the registry are indexed under Cancer Pain; 73 are open to participants now.
This study's enrollment of 330 is above the median of 62 across 235 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Cephalon is the lead sponsor of 75 studies on the registry; none are open to participants now.
First submitted before Cephalon became part of Teva Pharmaceutical Industries, Ltd..
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. 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.
Drug: Fentanyl Buccal Tablet (FBT)
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. 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.
Drug: Fentanyl Buccal Tablet (FBT)
FBTs were self-administered by participants via the oral mucosa. During the open-label dose titration period, participants used 1 to 4 tablets of the 100 mcg or 200 mcg strength to individually titrate upwards to an effective dose through the range of available strengths (i.e. 100, 200, 400, 600, or 800 mcg). For the open-label treatment and continuation periods, single dose tablets at the effective dose identified during the titration period were used. The maximum dose allowed per breakthrough pain (BTP) episode was 800 mcg. On any single day, participants were not to use FBT for more than 4 BTP episodes.
Also known as: Fentora, CEP-25608, Fentanyl citrate, Effentora
Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period
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.
Time frame: Day 1 up to Day 7
Kaplan-Meier Estimates for Time to Meaningful Pain Relief As Assessed by Participants During the Treatment Period For Overall Breakthrough Pain (BTP) Episodes
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.
Time frame: approximately Day 8-15
Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period
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.
Time frame: Day 1 up to Day 7
Breakthrough Pain (BTP) Episodes Requiring the Use of Rescue Medication During the Titration Period and the Treatment 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.
Time frame: Days 1 to up to Day 7 (Titration Period); approximately Day 8 up to Day 15 (Treatment Period)
Participant Assessment of Medication Performance During the Treatment Period
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).
Time frame: approximately Day 8-15
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: General Activity
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.
Time frame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Mood
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.
Time frame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Walking Ability
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.
Time frame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Normal Work
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.
Time frame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
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
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.
Time frame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Sleep
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.
Time frame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
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
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.
Time frame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire: Global Score
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.
Time frame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period
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.
Time frame: approximately Day 15 (end of Treatment Period)
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
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.
Time frame: approximately Day 15 (end of Treatment Period)
Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period
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.
Time frame: approximately Day 15 (end of Treatment Period)
Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period
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.
Time frame: approximately Day 15 (end of Treatment Period)
Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period
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.
Time frame: approximately Day 15 (end of Treatment Period)
Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period
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.
Time frame: approximately Day 15 (end of Treatment Period)
Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period
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.
Time frame: approximately Day 15 (end of Treatment Period)
Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period
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.
Time frame: approximately Day 15 (end of Treatment Period)
Participant's Global Assessment of Ease of Use at the End of the Treatment Period
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).
Time frame: approximately Day 15 (end of Treatment Period)
Participant's Global Impression of Change at the End of the Treatment Period
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).
Time frame: approximately Day 15 (end of Treatment Period)
Participants With Adverse Events (AE) Summarized by Treatment Period
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.
Time frame: Day 1-7 (Titration Period). Day 8-15 (Treatment Period), Days 16-688 (Continuation Period)
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.
| Milestone | FBT 100 Mcg - Dose Titration Period | FBT 200 Mcg - Dose Titration Period | FBT - Treatment and Continuation Periods |
|---|---|---|---|
| Started | 156 | 174 | 0 |
| Titration safety analysis set | 145 | 167 | 0 |
| Completed | 130 | 151 | 0 |
| Not completed | 26 | 23 | 0 |
| Withdrew: Adverse event | 11 | 10 | 0 |
| Withdrew: Lack of efficacy | 4 | 1 | 0 |
| Withdrew: Unstable persistent cancer pain | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 6 | 0 |
| Withdrew: Other | 5 | 4 | 0 |
| Withdrew: Non-compliance to study procedures | 1 | 1 | 0 |
| Withdrew: Non-compliance to study drug | 2 | 1 | 0 |
| Milestone | FBT 100 Mcg - Dose Titration Period | FBT 200 Mcg - Dose Titration Period | FBT - Treatment and Continuation Periods |
|---|---|---|---|
| Started | 0 | 0 | 281 |
| Safety analysis set | 0 | 0 | 223 |
| Completed | 0 | 0 | 218 |
| Not completed | 0 | 0 | 63 |
| Withdrew: Adverse event | 0 | 0 | 15 |
| Withdrew: Lack of efficacy | 0 | 0 | 6 |
| Withdrew: Unstable persistent cancer pain | 0 | 0 | 5 |
| Withdrew: Withdrawal by subject | 0 | 0 | 11 |
| Withdrew: Consistently >4 btp episodes daily | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 2 |
| Withdrew: Other | 0 | 0 | 18 |
| Withdrew: Non-compliance to study procedures | 0 | 0 | 4 |
| Withdrew: Unclear completion status | 0 | 0 | 1 |
| Milestone | FBT 100 Mcg - Dose Titration Period | FBT 200 Mcg - Dose Titration Period | FBT - Treatment and Continuation Periods |
|---|---|---|---|
| Started | 0 | 0 | 88 |
| Continuation safety analysis set | 0 | 0 | 87 |
| Completed | 0 | 0 | 27 |
| Not completed | 0 | 0 | 61 |
| Withdrew: Adverse event | 0 | 0 | 32 |
| Withdrew: Lack of efficacy | 0 | 0 | 6 |
| Withdrew: Unstable persistent cancer pain | 0 | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 0 | 10 |
| Withdrew: Other | 0 | 0 | 7 |
| Withdrew: Non-compliance to study procedures | 0 | 0 | 2 |
| Withdrew: Non-compliance to study drug | 0 | 0 | 1 |
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.
| percentage of treated participants | FBT 100 Mcg - Dose Titration Period | FBT 200 Mcg - Dose Titration Period |
|---|---|---|
| Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period | 75.2 | 81.2 |
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.
| minutes | FBT - Treatment Period |
|---|---|
| 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 (12.00 to 30.00) |
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.
| participants | FBT 100 Mcg - Dose Titration Period | FBT 200 Mcg - Dose Titration Period |
|---|---|---|
| 100 mcg | 34 | 7 |
| 200 mcg | 38 | 61 |
| 300 mcg (evaluated by mistake) | 1 | 1 |
| 400 mcg | 23 | 42 |
| 600 mcg | 8 | 15 |
| 800 mcg | 5 | 10 |
| Missing | 36 | 31 |
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.
| BTP episodes | During Titration Period | During Treatment Period |
|---|---|---|
| Breakthrough Pain (BTP) Episodes Requiring the Use of Rescue Medication During the Titration Period and the Treatment Period | 102 | 153 |
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).
| BTP episodes | 30 Minutes | 60 Minutes |
|---|---|---|
| Excellent | 103 | 144 |
| Very good | 433 | 584 |
| Good | 712 | 646 |
| Fair | 428 | 245 |
| Poor | 100 | 49 |
| Missing | 35 | 143 |
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.
| units on a scale | FBT - Treatment Period |
|---|---|
| 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 ± 2.52 |
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.
| units on a scale | FBT - Treatment Period |
|---|---|
| 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 ± 2.55 |
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.
| units on a scale | FBT - Treatment Period |
|---|---|
| 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 ± 2.29 |
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.
| units on a scale | FBT - Treatment Period |
|---|---|
| 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 ± 2.61 |
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.
| units on a scale | FBT - Treatment Period |
|---|---|
| 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 ± 2.50 |
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.
| units on a scale | FBT - Treatment Period |
|---|---|
| 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 ± 2.66 |
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.
| units on a scale | FBT - Treatment Period |
|---|---|
| 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 ± 2.77 |
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.
| units on a scale | FBT - Treatment Period |
|---|---|
| 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 ± 13.47 |
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.
| participants | FBT - Treatment Period |
|---|---|
| Very much | 64 |
| Quite a bit | 92 |
| Somewhat | 37 |
| A little bit | 8 |
| Not at all | 2 |
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.
| participants | FBT - Treatment Period |
|---|---|
| Very much | 55 |
| Quite a bit | 104 |
| Somewhat | 27 |
| A little bit | 13 |
| Not at all | 3 |
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.
| participants | FBT - Treatment Period |
|---|---|
| Very much | 63 |
| Quite a bit | 88 |
| Somewhat | 36 |
| A little bit | 12 |
| Not at all | 4 |
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.
| participants | FBT - Treatment Period |
|---|---|
| Very much | 57 |
| Quite a bit | 104 |
| Somewhat | 35 |
| A little bit | 5 |
| Not at all | 2 |
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.
| participants | FBT - Treatment Period |
|---|---|
| Very much | 81 |
| Quite a bit | 74 |
| Somewhat | 31 |
| A little bit | 9 |
| Not at all | 8 |
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.
| participants | FBT - Treatment Period |
|---|---|
| Very much | 81 |
| Quite a bit | 78 |
| Somewhat | 26 |
| A little bit | 10 |
| Not at all | 8 |
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.
| participants | FBT - Treatment Period |
|---|---|
| Very much | 96 |
| Quite a bit | 88 |
| Somewhat | 17 |
| A little bit | 2 |
| Not at all | 0 |
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.
| participants | FBT - Treatment Period |
|---|---|
| Very much | 107 |
| Quite a bit | 81 |
| Somewhat | 13 |
| A little bit | 2 |
| Not at all | 0 |
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).
| participants | FBT - Treatment Period |
|---|---|
| Very easy | 67 |
| Easy | 107 |
| Fair | 28 |
| Poor | 7 |
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).
| participants | FBT - Treatment Period |
|---|---|
| Very much improved | 15 |
| Much improved | 75 |
| Minimally improved | 65 |
| No change | 32 |
| Minimally worse | 14 |
| Much worse | 7 |
| Very much worse | 0 |
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.
| participants | FBT 100 Mcg - Dose Titration Period | FBT 200 Mcg - Dose Titration Period | FBT - Treatment Period | FBT - Continuation Period |
|---|---|---|---|---|
| Any AE | 44 | 74 | 43 | 72 |
| Any Serious AE | 8 | 12 | 4 | 37 |
| AE leading to discontinuation of study drug | 11 | 19 | 0 | 25 |
| AE with a fatal outcome | 6 | 4 | 3 | 29 |
| AE considered related to study drug | 19 | 35 | 15 | 14 |
Collected over Treatment-emergent AEs from Day 1 up to day 688. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FBT - All Doses and Study Periods | — | 67/312 (21.5%) | 52/312 (16.7%) |
| Event | FBT - All Doses and Study Periods |
|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 21/312 |
| Renal failureRenal and urinary disorders | 5/312 |
| VomitingGastrointestinal disorders | 4/312 |
| AnaemiaBlood and lymphatic system disorders | 3/312 |
| PyrexiaGeneral disorders | 3/312 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 3/312 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/312 |
| Cardio-respiratory arrestCardiac disorders | 2/312 |
| DysphagiaGastrointestinal disorders | 2/312 |
| Intestinal obstructionGastrointestinal disorders | 2/312 |
| Event | FBT - All Doses and Study Periods |
|---|---|
| NauseaGastrointestinal disorders | 30/312 |
| VomitingGastrointestinal disorders | 23/312 |
| SomnolenceNervous system disorders | 16/312 |
| Age Continuous(years) | FBT 100 Mcg - Dose Titration Period | FBT 200 Mcg - Dose Titration Period | Total |
|---|---|---|---|
| Mean | 59.5 ± 11.72 | 60.1 ± 10.97 | 59.8 ± 11.32 |
| Sex: Female, Male(Participants) | FBT 100 Mcg - Dose Titration Period | FBT 200 Mcg - Dose Titration Period | Total |
|---|---|---|---|
| Female | 71 | 78 | 149 |
| Male | 85 | 96 | 181 |
| Region of Enrollment(participants) | FBT 100 Mcg - Dose Titration Period | FBT 200 Mcg - Dose Titration Period | Total |
|---|---|---|---|
| France | 16 | 25 | 41 |
| Spain | 26 | 26 | 52 |
| Poland | 38 | 41 | 79 |
| Ireland | 1 | 0 | 1 |
| Germany | 32 | 38 | 70 |
| United Kingdom | 8 | 7 | 15 |
| Italy | 35 | 37 | 72 |
| Cancer Site(participants) | FBT 100 Mcg - Dose Titration Period | FBT 200 Mcg - Dose Titration Period | Total |
|---|---|---|---|
| Breast | 31 | 36 | 67 |
| Colon/rectum | 15 | 25 | 40 |
| Colon/rectum + Pancreas/stomach + other | 1 | 0 | 1 |
| Head/neck | 12 | 12 | 24 |
| Leukemia/lymphoma | 2 | 4 | 6 |
| Myeloma | 5 | 4 | 9 |
| Oesophageal | 4 | 2 | 6 |
| Pancreas/stomach | 13 | 11 | 24 |
| Prostate | 8 | 17 | 25 |
| Lung | 26 | 21 | 47 |
| Other (not specified) | 39 | 42 | 81 |
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Studies of the drug tested here: Fentanyl