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Status:

TERMINATED

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

Lead Sponsor:

Cephalon

Conditions:

Cancer Pain

Breakthrough Pain

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 o...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2011

Estimated Enrollment :

330 Patients enrolled

Trial Details

Trial ID

NCT00842829

Start Date

January 1 2009

End Date

May 1 2011

Last Update

October 1 2012

Active Locations (123)

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Page 1 of 31 (123 locations)

1

Investigational Site

Bayonne, France, 64100

2

Investigational Site

Bordeaux, France, 33075

3

Investigational Site

Caen, France, 14033

4

Investigational Site

Clichy, France, 92110