Symptoms and General Pathology

All Conditions

Nervous System Diseases

Cancer Pain

Pain

Breakthrough Pain

Neurologic Manifestations

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

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Fentanyl

Analgesics, Opioid

Citric Acid

Sodium Citrate

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Citrate

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.

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.

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.

Fentanyl Buccal Tablet (FBT)

Sponsor's Medical Expert

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.

Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

A European Multicenter Open-Label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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 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.

Cephalon

Participants took fentanyl buccal tables (FBT) with doses between 100-800 mcg

FBT - All Doses and Study Periods

During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.

FBT 100 Mcg - Dose Titration Period

During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.

FBT 200 Mcg - Dose Titration Period

Total

Age Continuous

Sex: Female, Male

France

Spain

Poland

Ireland

Germany

United Kingdom

Italy

Region of Enrollment

Breast

Colon/rectum

Colon/rectum + Pancreas/stomach + other

Head/neck

Leukemia/lymphoma

Myeloma

Oesophageal

Pancreas/stomach

Prostate

Lung

Other (not specified)

Cancer Site

Director, Clinical Research

Treatment comparison difference (100 mcg - 200 mcg)

Titration safety analysis set consisting of participants who took at least one dose of study medication.

Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period

Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).

FBT - Treatment Period

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.

Kaplan-Meier Estimates for Time to Meaningful Pain Relief As Assessed by Participants During the Treatment Period For Overall Breakthrough Pain (BTP) Episodes

100 mcg

200 mcg

300 mcg (evaluated by mistake)

400 mcg

600 mcg

800 mcg

Missing

Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period

The titration period consisted of up to 7 days of treatment in which participants used increasing dosage of study drug in order to identify the effective dose for their breakthrough pain episodes.

During Titration Period

The treatment period included participants who identified an effective dose during the earlier study period and used that dose for BTP episodes during the Treatment Period.

During Treatment Period

Safety analysis set consisting of participants who took at least one dose of study drug during the relevant study period.

Breakthrough Pain (BTP) Episodes Requiring the Use of Rescue Medication During the Titration Period and the Treatment Period

Excellent

Very good

Good

Fair

Poor

Participant assessments of medication performance 30 minutes after dosing during the Treatment Period.

30 Minutes

Participant assessments of medication performance 60 minutes after dosing during the Treatment Period.

60 Minutes

Safety analysis set of participants with a response at the time point (30 or 60 minutes) post dose.

Participant Assessment of Medication Performance During the Treatment Period

Safety analysis set of participants with both baseline and Treatment Period responses

Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: General Activity

Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Mood

Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Walking Ability

Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Normal Work

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

Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Sleep

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

Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire: Global Score

Very much

Quite a bit

Somewhat

A little bit

Not at all

Safety analysis set of participants with a response

Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the 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

Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period

Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period

Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the 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

Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period

Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period

Very easy

Easy

Participant's Global Assessment of Ease of Use at the End of the Treatment Period

Very much improved

Much improved

Minimally improved

No change

Minimally worse

Much worse

Very much worse

Participant's Global Impression of Change at the End of the Treatment Period

Any AE

Any Serious AE

AE leading to discontinuation of study drug

AE with a fatal outcome

AE considered related to study drug

The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.

FBT - Continuation Period

Participants With Adverse Events (AE) Summarized by Treatment Period

Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days). The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients	NCT00842829	Cancer Pain Breakthrough Pa...	Fentanyl Buccal...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients	NCT00842829	Cancer Pain Breakthrough Pa...	Fentanyl Buccal...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.

Spots Global Cancer Trial Database for fentanyl buccal tablet (fbt)