Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
Completed
BioDelivery Sciences International
Phase 3
2006-02-01
The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) 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.
This study is designed to provide continued access to BEMA Fentanyl for those subjects who
previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the
treatment of their breakthrough cancer pain.
This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the
use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in
less respiratory depression while providing better compliance with the procedure.
This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the
use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in
less respiratory depression while providing better compliance with the procedure.
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