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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001841-24 | EudraCT Number |
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Recruitment stopped at the end of the recruitment timeframe
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FBT 100 mcg | Experimental | 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. |
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| FBT 200 mcg | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 up to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sponsor's Medical Expert | Cephalon Europe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Bayonne | 64100 | France | |||
| Investigational Site |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | FBT 200 Mcg - Dose Titration Period |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Titration Period |
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| 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | Day 1-7 (Titration Period). Day 8-15 (Treatment Period), Days 16-688 (Continuation Period) |
| Bordeaux |
| 33075 |
| France |
| Investigational Site | Caen | 14033 | France |
| Investigational Site | Clichy | 92110 | France |
| Investigational Site | Grenoble | 38043 | France |
| Investigational Site | Le Chesnay | 78157 | France |
| Investigational Site | Le Kremlin-Bicêtre | 94275 | France |
| Investigational Site | Le Mans | 72018 | France |
| Investigational Site | Lorient | 58107 | France |
| Investigational Site | Montpellier | 34298 | France |
| Investigational Site | Nevers | 58033 | France |
| Investigational Site | Orléans | 45032 | France |
| Investigational Site | Paris | 75010 | France |
| Investigational Site | Paris | 75013 | France |
| Investigational Site | Paris | 75730 | France |
| Investigational Site | Pierre-Bénite | 69495 | France |
| Investigational Site | Poitiers | 86021 | France |
| Investigational Site | Rouen | 76031 | France |
| Investigational Site | Saint-Herblain | 44805 | France |
| Investigational Site | Tarbes | 65000 | France |
| Investigational Site | Toulouse | 31059 | France |
| Investigational Site | Villejuif | 94800 | France |
| Investigational Site | Bad Honnef | 53604 | Germany |
| Investigational Site | Bad Lippspringe | 33175 | Germany |
| Investigational Site | Berlin | 10435 | Germany |
| Investigational Site | Berlin | 13353 | Germany |
| Investigational Site | Berlin | 13585 | Germany |
| Investigational Site | Berlin | 14089 | Germany |
| Investigational Site | Bonn | 53111 | Germany |
| Investigational Site | Böhlen | 04564 | Germany |
| Investigational Site | Dresden | 01307 | Germany |
| Investigational Site | Duisburg | 47055 | Germany |
| Investigational Site | Duisburg | 47166 | Germany |
| Investigational Site | Erfurt | 99084 | Germany |
| Investigational Site | Freiburg im Breisgau | 79108 | Germany |
| Investigational Site | Geesthacht | 21502 | Germany |
| Investigational Site | Greifenstein | 35753 | Germany |
| Investigational Site | Hanover | 30625 | Germany |
| Investigational Site | Herne | 44623 | Germany |
| Investigational Site | Hildesheim | 31135 | Germany |
| Investigational Site | Jena | 07747 | Germany |
| Investigational Site | Kassel | 34117 | Germany |
| Investigational Site | Leipzig | 04107 | Germany |
| Investigational Site | Lohsa | 02999 | Germany |
| Investigational Site | Lünen | 44534 | Germany |
| Investigational Site | Mainz | 55131 | Germany |
| Investigational Site | Munich | 80637 | Germany |
| Investigational Site | Munich | 81377 | Germany |
| Investigational Site | Mülhausen | 99974 | Germany |
| Investigational Site | Neustadt | 01844 | Germany |
| Investigational Site | Rostock | 18059 | Germany |
| Investigational Site | Weiden | 92637 | Germany |
| Investigational Site | Würselen | 52146 | Germany |
| Investigational Site | Dublin | Ireland |
| Investigational Site | Aviano | 33081 | Italy |
| Investigational Site | Bari | 70120 | Italy |
| Investigational Site | Brescia | 25123 | Italy |
| Investigational Site | Cagliari | 9121 | Italy |
| Investigational Site | Candiolo | 10060 | Italy |
| Investigational Site | Caserta | 81100 | Italy |
| Investigational Site | Cosenza | 87100 | Italy |
| Investigational Site | Florence | 50100 | Italy |
| Investigational Site | Garbagnate Milanese | 20024 | Italy |
| Investigational Site | Genova | 16128 | Italy |
| Investigational Site | Lugo | 48022 | Italy |
| Investigational Site | L’Aquila | 67100 | Italy |
| Investigational Site | Milan | 20142 | Italy |
| Investigational Site | Modena | 41100 | Italy |
| Investigational Site | Naples | 80131 | Italy |
| Investigational Site | Palermo | 90146 | Italy |
| Investigational Site | Piacenza | 29100 | Italy |
| Investigational Site | Pisa | 56100 | Italy |
| Investigational Site | Roma | 133 | Italy |
| Investigational Site | Roma | 144 | Italy |
| Investigational Site | Roma | 161 | Italy |
| Investigational Site | Torino | 10126 | Italy |
| Investigational Site | Torino | 10153 | Italy |
| Investigational Site | Verona | 37024 | Italy |
| Investigational Site | Bielsko-Biala | 43300 | Poland |
| Investigational Site | Bydgoszcz | 85796 | Poland |
| Investigational Site | Elblag | 82300 | Poland |
| Investigational Site | Gdansk | 80208 | Poland |
| Investigational Site | Gdansk | 80952 | Poland |
| Investigational Site | Gliwice | 44101 | Poland |
| Investigational Site | Lodz | 90251 | Poland |
| Investigational Site | Poznan | 60245 | Poland |
| Investigational Site | Poznan | 61866 | Poland |
| Investigational Site | Puszczykowo | 62041 | Poland |
| Investigational Site | Szczecin | 71730 | Poland |
| Investigational Site | Szczecin | 71740 | Poland |
| Investigational Site | Tychy | 43100 | Poland |
| Investigational Site | Warsaw | 02781 | Poland |
| Investigational Site | Wroclaw | 53413 | Poland |
| Investigational Site | Włocławek | 87800 | Poland |
| Investigational Site | A Coruña | 15006 | Spain |
| Investigational Site | A Coruña | 15009 | Spain |
| Investigational Site | Barcelona | 08025 | Spain |
| Investigational Site | Barcelona | 08907 | Spain |
| Investigational Site | Bilbao | 48013 | Spain |
| Investigational Site | Cadiz | 11009 | Spain |
| Investigational Site | Córdoba | 14002 | Spain |
| Investigational Site | Granada | 18012 | Spain |
| Investigational Site | Lleida | 28195 | Spain |
| Investigational Site | Madrid | 28006 | Spain |
| Investigational Site | Madrid | 28035 | Spain |
| Investigational Site | Madrid | 28046 | Spain |
| Investigational Site | Palma de Mallorca | 07012 | Spain |
| Investigational Site | Pamplona | 31008 | Spain |
| Investigational Site | Salamanca | 37007 | Spain |
| Investigational Site | San Cristóbal de La Laguna | 38320 | Spain |
| Investigational Site | Santander | 39008 | Spain |
| Investigational Site | Santiago de Compostela | 15706 | Spain |
| Investigational Site | Seville | 41009 | Spain |
| Investigational Site | Seville | 41013 | Spain |
| Investigational Site | Valencia | 46014 | Spain |
| Investigational Site | Valencia | 46015 | Spain |
| Investigational Site | Bath | BA15 2LG | United Kingdom |
| Investigational Site | Dumfries | DG1 4AP | United Kingdom |
| Investigational Site | London | SW3 6JJ | United Kingdom |
| Investigational Site | Nottingham | NG5 1PB | United Kingdom |
| Investigational Site | Plymouth | PL68DH | United Kingdom |
| Investigational Site | Surrey | KT10 8NA | United Kingdom |
| Investigational Site | Sutton | SM2 5PT | United Kingdom |
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. |
| FG002 | 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. |
| Titration Safety Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period |
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| Continuation Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cancer Site | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Titration safety analysis set consisting of participants who took at least one dose of study medication. | Posted | Number | percentage of treated participants | Day 1 up to Day 7 |
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| Secondary | 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. | 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. | Posted | Median | Inter-Quartile Range | minutes | approximately Day 8-15 | breakthrough pain episodes | Participants |
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| Secondary | 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. | Titration safety analysis set consisting of participants who took at least one dose of study medication. | Posted | Number | participants | Day 1 up to Day 7 |
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| Secondary | 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. | Safety analysis set consisting of participants who took at least one dose of study drug during the relevant study period. | Posted | Number | BTP episodes | Days 1 to up to Day 7 (Titration Period); approximately Day 8 up to Day 15 (Treatment Period) | breakthrough pain episodes | Participants |
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| Secondary | 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). | Safety analysis set of participants with a response at the time point (30 or 60 minutes) post dose. | Posted | Number | BTP episodes | approximately Day 8-15 | breakthrough pain episodes | Participants |
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| Secondary | 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. | Safety analysis set of participants with both baseline and Treatment Period responses | Posted | Mean | Standard Deviation | units on a scale | Day 0 (baseline), approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with both baseline and Treatment Period responses | Posted | Mean | Standard Deviation | units on a scale | Day 0 (baseline), approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with both baseline and Treatment Period responses | Posted | Mean | Standard Deviation | units on a scale | Day 0 (baseline), approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with both baseline and Treatment Period responses | Posted | Mean | Standard Deviation | units on a scale | Day 0 (baseline), approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with both baseline and Treatment Period responses | Posted | Mean | Standard Deviation | units on a scale | Day 0 (baseline), approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with both baseline and Treatment Period responses | Posted | Mean | Standard Deviation | units on a scale | Day 0 (baseline), approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with both baseline and Treatment Period responses | Posted | Mean | Standard Deviation | units on a scale | Day 0 (baseline), approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with both baseline and Treatment Period responses | Posted | Mean | Standard Deviation | units on a scale | Day 0 (baseline), approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with a response | Posted | Number | participants | approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with a response | Posted | Number | participants | approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with a response | Posted | Number | participants | approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with a response | Posted | Number | participants | approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with a response | Posted | Number | participants | approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with a response | Posted | Number | participants | approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with a response | Posted | Number | participants | approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set of participants with a response | Posted | Number | participants | approximately Day 15 (end of Treatment Period) |
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| Secondary | 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). | Safety analysis set of participants with a response | Posted | Number | participants | approximately Day 15 (end of Treatment Period) |
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| Secondary | 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). | Safety analysis set of participants with a response | Posted | Number | participants | approximately Day 15 (end of Treatment Period) |
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| Secondary | 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. | Safety analysis set | Posted | Number | participants | Day 1-7 (Titration Period). Day 8-15 (Treatment Period), Days 16-688 (Continuation Period) |
|
Treatment-emergent AEs from Day 1 up to day 688
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FBT - All Doses and Study Periods | Participants took fentanyl buccal tables (FBT) with doses between 100-800 mcg | 67 | 312 | 52 | 312 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tachycardia paroxysmal | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oedema mouth | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tongue oedema | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Superior vena caval occlusion | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc. | 215-591-3000 | ustevatrials@tevapharm.com |
| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D059390 | Breakthrough Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Unstable persistent cancer pain |
|
| Withdrawal by Subject |
|
| Consistently >4 BTP episodes daily |
|
| Protocol Violation |
|
| Other |
|
| Non-compliance to study procedures |
|
| Unclear completion status |
|
| Unstable persistent cancer pain |
|
| Withdrawal by Subject |
|
| Other |
|
| Non-compliance to study procedures |
|
| Non-compliance to study drug |
|
| Male |
|
| Spain |
|
| Poland |
|
| Ireland |
|
| Germany |
|
| United Kingdom |
|
| Italy |
|
| Colon/rectum |
|
| Colon/rectum + Pancreas/stomach + other |
|
| Head/neck |
|
| Leukemia/lymphoma |
|
| Myeloma |
|
| Oesophageal |
|
| Pancreas/stomach |
|
| Prostate |
|
| Lung |
|
| Other (not specified) |
|
| breakthrough pain episodes |
|
|
| Units | Counts |
|---|---|
| Participants |
|
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| breakthrough pain episodes |
|
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| breakthrough pain episodes |
|
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|
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|
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|
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| OG003 | 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. |
|
|