Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293033
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2006-02-15
Brief Title:
Study of BEMA Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
Sponsor:
BioDelivery Sciences International
Organization:
BioDelivery Sciences International
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-11
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 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 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
Detailed Description:
This is a randomized double-blind placebo controlled multiple cross-over study Eligible subjects will be treated with open label BEMA fentanyl over a period of up to two weeks Doses will be titrated upward starting at 200 μg until a dose is identified that produces satisfactory pain relief for at least 2 episodes Those subjects who identify a dose of BEMA fentanyl that produces satisfactory relief of breakthrough pain episodes will enter the double-blind placebo controlled period of the trial They will receive 3 placebo doses and 6 BEMA fentanyl doses in a random sequence per randomization schedule
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