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NCT00842829

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

Last Updated: 2012-10-01

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Pain Breakthrough Pain

Keywords

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Breakthrough Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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FBT 100 mcg

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.

Group Type EXPERIMENTAL

Fentanyl Buccal Tablet (FBT)

Intervention Type 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.

FBT 200 mcg

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.

Group Type ACTIVE_COMPARATOR

Fentanyl Buccal Tablet (FBT)

Intervention Type DRUG

Interventions

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Fentanyl Buccal Tablet (FBT)

Intervention Type DRUG

Other Intervention Names

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Fentora CEP-25608 Fentanyl citrate Effentora

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sponsor's Medical Expert

Role: STUDY_DIRECTOR

Cephalon Europe

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Netherlands France Germany Ireland Italy Poland Spain United Kingdom

Other Identifiers

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2008-001841-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C25608/4027/BP/EU

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

FBT 100 mcg

Fentanyl Buccal Tablet (FBT)

FBT 200 mcg

Fentanyl Buccal Tablet (FBT)

Interventions

Fentanyl Buccal Tablet (FBT)

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Cephalon

Responsible Party

Principal Investigators

Sponsor's Medical Expert

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