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

Phase 4
18 Years
Not Enrolling
Cancer Pain, Breakthrough Pain

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Trial Information

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

Inclusion Criteria:

- The patient is willing to provide written informed consent to participate in this

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Day 1 up to Day 7

Safety Issue:


Principal Investigator

Sponsor's Medical Expert

Investigator Role:

Study Director

Investigator Affiliation:

Cephalon Europe


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2009

Completion Date:

May 2011

Related Keywords:

  • Cancer Pain
  • Breakthrough Pain
  • Breakthrough Cancer Pain