Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy - Full Text View

Sponsor:	BioDelivery Sciences International
Information provided by:	BioDelivery Sciences International
ClinicalTrials.gov Identifier:	NCT00293020

Purpose

The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption.

BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive) fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the disc are water soluble, so the entire dosage form dissolves within 30 minutes of application.

Condition	Intervention	Phase
Pain Cancer	Drug: BEMA Fentanyl	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label, Long-term Treatment Evaluation of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy

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 BioDelivery Sciences International:

Primary Outcome Measures:

Evaluation of the safety and tolerability of BEMA Fentanyl. The safety assessments will include oral exams for mucosal irritation, adverse events, vital signs, physical examinations and concomitant medications. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	320
Study Start Date:	February 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 BEMA Fentanyl	Drug: BEMA Fentanyl buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily Other Name: bioerodible mucoadhesive system

Eligibility

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

Criteria

Inclusion Criteria:

Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control.
18 years or older
Patient must have pain associated with cancer or cancer treatment
Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000 mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30 mg, methadone 20 mg, and hydromorphone 7.5 mg)
Regularly experience 1 - 4 breakthrough pain episodes per day that require additional opioids for pain control
At least partial relief of breakthrough pain by use of opioid therapy
Subject must be able to self-administer the study medication correctly.
Subject must be willing and able to complete the electronic diary card with each pain episode.
Signed consent must be obtained at screening prior to any procedures being performed.

Exclusion Criteria:

Psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary
Cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression
Recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse
Rapidly escalating pain that the investigator believes may require an increase in the dosage of background pain medication during the study
Moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the BEMA disc at a site of inflammation)
Strontium 89 therapy within the previous 6 months
Any other therapy prior to the study that the investigator considers could alter pain or the response to pain medication.
Use of an investigational drug within 4 weeks preceding this study • History of hypersensitivity or intolerance to fentanyl
Regularly more than 4 episodes per day
ECOG performance status of 4 or 5
Subject is pregnant, actively trying to become pregnant, breast feeding or not using adequate contraceptive measures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293020

Locations

United States, Texas
ResearchPoint
Austin, Texas, United States, 78746

Sponsors and Collaborators

BioDelivery Sciences International

Investigators

Study Chair:

David Blum, MD

BioDelivery Sciences International

More Information

No publications provided

Responsible Party:	David Blum, MD, Vice President, Medical Affairs and Clinical Research, BioDelivery Sciences International
ClinicalTrials.gov Identifier:	NCT00293020 History of Changes
Other Study ID Numbers:	FEN-202
Study First Received:	February 15, 2006
Last Updated:	July 29, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by BioDelivery Sciences International:

Breakthrough Pain in Cancer Patients

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