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

NCT ID: NCT00293020

Last Updated: 2012-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-06-30

Brief Summary

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.

Conditions

Pain; Cancer

Keywords

Breakthrough Pain in Cancer Patients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

BEMA Fentanyl

Group Type: EXPERIMENTAL

BEMA Fentanyl

Intervention Type: DRUG

buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily

Interventions

BEMA Fentanyl

buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily

Intervention Type: DRUG

Other Intervention Names

bioerodible mucoadhesive system

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioDelivery Sciences International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Blum, MD

Role: STUDY_CHAIR

BioDelivery Sciences International

Locations

ResearchPoint

Austin, Texas, United States

Countries

United States

Other Identifiers

FEN-202

Identifier Type: -

Identifier Source: org_study_id