Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
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|ClinicalTrials.gov Identifier: NCT00293033|
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : January 18, 2008
The purpose of this study is to evaluate the efficacy 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 or disease||Intervention/treatment||Phase|
|Pain Cancer||Drug: BEMA™ Fentanyl||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Placebo Controlled Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
- Summary of Pain Intensity Differences
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293033
|United States, North Carolina|
|Wilmington, North Carolina, United States, 28412|
|Study Chair:||Andrew Finn, PharmD||BioDelivery Sciences International|