Clinical trial NCT00842829: Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
Official title: A European Multicenter Open-Label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cancer Pain
Breakthrough Pain
Keywords: Breakthrough Cancer Pain
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* The patient is willing to provide written informed consent to participate in this study.
* The patient can be either an out-patient or an in-patient.
* The patient has a histologically documented diagnosis of cancer.
* The patient has stable background pain due to cancer.
* The patient experiences up to 4 BTcP episodes per 24 hours.
* As maintenance opioid therapy, the patient is currently taking 1 of the following: at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of hydromorphone/day, of an equianalgesic dose of another opioid for a week or longer before administration of the first dose of study drug.
* Women of childbearing potential, using a medically accepted, highly effective method of birth control and agree to continued use of this method for the duration of the study.
* The patient must be willing and able to successfully self-administer the study drug and to fill in study documents.

Exclusion Criteria:

* The patient is without maintenance opioid therapy.
* The patient has uncontrolled or rapidly escalating pain as determined by the investigator.
* The patient has known or suspected hypersensitivities, allergies, or other contraindications to the active drug or to any of the excipients of the study drug.
* The patient has respiratory depression or chronic obstructive pulmonary disease, or any other medical condition predisposing to respiratory depression.
* The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
* The patient is expected to have surgery during the study.
* The patient is pregnant or lactating.
* The patient has participated in a study involving an investigational drug in the prior 30 days.
* The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
* The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that could, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.

Primary outcomes:
measure: Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period
timeFrame: Day 1 up to Day 7
Secondary outcomes:
measure: Kaplan-Meier Estimates for Time to Meaningful Pain Relief As Assessed by Participants During the Treatment Period For Overall Breakthrough Pain (BTP) Episodes
timeFrame: approximately Day 8-15
measure: Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period
timeFrame: Day 1 up to Day 7
measure: Breakthrough Pain (BTP) Episodes Requiring the Use of Rescue Medication During the Titration Period and the Treatment Period
timeFrame: Days 1 to up to Day 7 (Titration Period); approximately Day 8 up to Day 15 (Treatment Period)
measure: Participant Assessment of Medication Performance During the Treatment Period
timeFrame: approximately Day 8-15
measure: Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: General Activity
timeFrame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
measure: Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Mood
timeFrame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
measure: Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Walking Ability
timeFrame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
measure: Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Normal Work
timeFrame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
measure: 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
timeFrame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
measure: Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Sleep
timeFrame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
measure: 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
timeFrame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
measure: Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire: Global Score
timeFrame: Day 0 (baseline), approximately Day 15 (end of Treatment Period)
measure: Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period
timeFrame: approximately Day 15 (end of Treatment Period)
measure: 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
timeFrame: approximately Day 15 (end of Treatment Period)
measure: Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period
timeFrame: approximately Day 15 (end of Treatment Period)
measure: Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period
timeFrame: approximately Day 15 (end of Treatment Period)
measure: Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period
timeFrame: approximately Day 15 (end of Treatment Period)
measure: Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period
timeFrame: approximately Day 15 (end of Treatment Period)
measure: Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period
timeFrame: approximately Day 15 (end of Treatment Period)
measure: Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period
timeFrame: approximately Day 15 (end of Treatment Period)
measure: Participant's Global Assessment of Ease of Use at the End of the Treatment Period
timeFrame: approximately Day 15 (end of Treatment Period)
measure: Participant's Global Impression of Change at the End of the Treatment Period
timeFrame: approximately Day 15 (end of Treatment Period)
measure: Participants With Adverse Events (AE) Summarized by Treatment Period
timeFrame: Day 1-7 (Titration Period). Day 8-15 (Treatment Period), Days 16-688 (Continuation Period)
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Investigational Site
city: Bordeaux
country: France
facility: Investigational Site
city: Caen
country: France
facility: Investigational Site
city: Clichy
country: France
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city: Grenoble
country: France
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city: Le Chesnay
country: France
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city: Le Kremlin Bicetre
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city: Le Mans
country: France
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city: Lorient
country: France
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city: Montpellier
country: France
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city: Nevers
country: France
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city: Orleans
country: France
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city: Paris
country: France
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city: Paris
country: France
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city: Paris
country: France
facility: Investigational Site
city: Pierre Benite
country: France
facility: Investigational Site
city: Poitiers
country: France
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city: Rouen
country: France
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city: Saint Herblain
country: France
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city: Tarbes
country: France
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city: Toulouse
country: France
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city: Villejuif
country: France
facility: Investigational Site
city: Bad Honnef
country: Germany
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city: Bad Lippspringe
country: Germany
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city: Berlin
country: Germany
facility: Investigational Site
city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Bohlen
country: Germany
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city: Bonn
country: Germany
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city: Dresden
country: Germany
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city: Duisburg
country: Germany
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city: Duisburg
country: Germany
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city: Erfurt
country: Germany
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city: Freiburg
country: Germany
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city: Geesthacht
country: Germany
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city: Greifenstein
country: Germany
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city: Hannover
country: Germany
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city: Herne
country: Germany
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city: Hildesheim
country: Germany
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city: Jena
country: Germany
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city: Kassel
country: Germany
facility: Investigational Site
city: Leipzig
country: Germany
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city: Lohsa
country: Germany
facility: Investigational Site
city: Lunen
country: Germany
facility: Investigational Site
city: Mainz
country: Germany
facility: Investigational Site
city: Mulhausen
country: Germany
facility: Investigational Site
city: Munich
country: Germany
facility: Investigational Site
city: Munich
country: Germany
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city: Neustadt
country: Germany
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city: Rostock
country: Germany
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city: Weiden
country: Germany
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city: Wurselen
country: Germany
facility: Investigational Site
city: Dublin
country: Ireland
facility: Investigational Site
city: Aquila
country: Italy
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city: Aviano
country: Italy
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city: Bari
country: Italy
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city: Brescia
country: Italy
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city: Cagliari
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city: Candiolo
country: Italy
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city: Caserta
country: Italy
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city: Cosenza
country: Italy
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city: Firenze
country: Italy
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city: Garbagnate Milanese
country: Italy
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city: Genova
country: Italy
facility: Investigational Site
city: Lugo
country: Italy
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city: Milano
country: Italy
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city: Modena
country: Italy
facility: Investigational Site
city: Napoli
country: Italy
facility: Investigational Site
city: Palermo
country: Italy
facility: Investigational Site
city: Piacenza
country: Italy
facility: Investigational Site
city: Pisa
country: Italy
facility: Investigational Site
city: Roma
country: Italy
facility: Investigational Site
city: Roma
country: Italy
facility: Investigational Site
city: Roma
country: Italy
facility: Investigational Site
city: Torino
country: Italy
facility: Investigational Site
city: Torino
country: Italy
facility: Investigational Site
city: Verona
country: Italy
facility: Investigational Site
city: Bielsko Biala
country: Poland
facility: Investigational Site
city: Bydgoszcz
country: Poland
facility: Investigational Site
city: Elblag
country: Poland
facility: Investigational Site
city: Gdansk
country: Poland
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city: Gdansk
country: Poland
facility: Investigational Site
city: Gliwice
country: Poland
facility: Investigational Site
city: Lodz
country: Poland
facility: Investigational Site
city: Poznan
country: Poland
facility: Investigational Site
city: Poznan
country: Poland
facility: Investigational Site
city: Puszczykowo
country: Poland
facility: Investigational Site
city: Szczecin
country: Poland
facility: Investigational Site
city: Szczecin
country: Poland
facility: Investigational Site
city: Tychy
country: Poland
facility: Investigational Site
city: Warszawa
country: Poland
facility: Investigational Site
city: Wloclawek
country: Poland
facility: Investigational Site
city: Wroclaw
country: Poland
facility: Investigational Site
city: A Coruna
country: Spain
facility: Investigational Site
city: A Coruna
country: Spain
facility: Investigational Site
city: Barcelona
country: Spain
facility: Investigational Site
city: Barcelona
country: Spain
facility: Investigational Site
city: Bilbao
country: Spain
facility: Investigational Site
city: Cadiz
country: Spain
facility: Investigational Site
city: Cordoba
country: Spain
facility: Investigational Site
city: Granada
country: Spain
facility: Investigational Site
city: La Laguna
country: Spain
facility: Investigational Site
city: LLeida
country: Spain
facility: Investigational Site
city: Madrid
country: Spain
facility: Investigational Site
city: Madrid
country: Spain
facility: Investigational Site
city: Madrid
country: Spain
facility: Investigational Site
city: Palma de Mallorca
country: Spain
facility: Investigational Site
city: Pamplona
country: Spain
facility: Investigational Site
city: Salamanca
country: Spain
facility: Investigational Site
city: Santander
country: Spain
facility: Investigational Site
city: Santiago de Compostela
country: Spain
facility: Investigational Site
city: Sevilla
country: Spain
facility: Investigational Site
city: Sevilla
country: Spain
facility: Investigational Site
city: Valencia
country: Spain
facility: Investigational Site
city: Valencia
country: Spain
facility: Investigational Site
city: Bath
country: United Kingdom
facility: Investigational Site
city: Dumfries
country: United Kingdom
facility: Investigational Site
city: London
country: United Kingdom
facility: Investigational Site
city: Nottingham
country: United Kingdom
facility: Investigational Site
city: Plymouth
country: United Kingdom
facility: Investigational Site
city: Surrey
country: United Kingdom
facility: Investigational Site
city: Sutton
country: United Kingdom
facility: Investigational Site
Study officials:
affiliation: Cephalon Europe
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References: