Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293020
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2006-02-15
Brief Title:
Study of the Safety of BEMA Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
Sponsor:
BioDelivery Sciences International
Organization:
BioDelivery Sciences International
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None