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

Sponsor:	Cephalon
Information provided by (Responsible Party):	Cephalon
ClinicalTrials.gov Identifier:	NCT00842829

Purpose

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.

Condition	Intervention	Phase
Cancers, Pain	Drug: Fentanyl Buccal Tablet (FBT)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	A European Multicenter Open-Label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Cephalon:

Primary Outcome Measures:

Number of patients reaching an effective FBT dose, between two starting doses (100 mcg or 200 mcg) [ Time Frame: 7 days (titration period) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of FBT treatment for breakthrough cancer pain (BTcP) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	429
Study Start Date:	January 2009
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 During the Titration period, individual patients are titrated upwards to an effective Fentanyl Buccal Tablet (FBT) dose. An Open-Label Treatment period follows. Some patients may then enter an Open-Label Continuation period.	Drug: Fentanyl Buccal Tablet (FBT) FBT starting dose: 100 mcg (with a maximum dose allowed of 800 mcg per breakthrough pain (BTP) episode)
Active Comparator: 2 During the Titration period, individual patients are titrated upwards to an effective Fentanyl Buccal Tablet (FBT) dose. An Open-Label Treatment period follows. Some patients may then enter an Open-Label Continuation period.	Drug: Fentanyl Buccal Tablet (FBT) FBT starting dose: 200 mcg (with a maximum dose allowed of 800 mcg per breakthrough cancer pain (BTcP) episode, and a possible 100 mcg if needed)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842829

Show 127 Study Locations

Sponsors and Collaborators

Cephalon

Investigators

Study Director:

Sponsor's Medical Expert

Cephalon Europe

More Information

No publications provided

Responsible Party:	Cephalon
ClinicalTrials.gov Identifier:	NCT00842829 History of Changes
Other Study ID Numbers:	C25608/4027/BP/EU
Study First Received:	January 29, 2009
Last Updated:	December 30, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Ireland: Irish Medicines Board; Italy: The Italian Medicines Agency; Netherlands: Ministry of Health, Welfare and Sport; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cephalon:

Breakthrough Cancer Pain

Additional relevant MeSH terms:

Fentanyl
Analgesics, Opioid
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants

Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on February 09, 2012