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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International
ClinicalTrials.gov Identifier:
NCT00293020
First received: February 15, 2006
Last updated: September 6, 2012
Last verified: September 2012
  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 3

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:


Further study details as provided by BioDelivery Sciences International:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events. [ Time Frame: Participants were followed for the duration of the study, an average of 126 days ] [ Designated as safety issue: Yes ]
    After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.


Enrollment: 244
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT00293020     History of Changes
Other Study ID Numbers: FEN-202
Study First Received: February 15, 2006
Results First Received: February 13, 2012
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by BioDelivery Sciences International:
Breakthrough Pain in Cancer Patients

Additional relevant MeSH terms:
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 26, 2014