Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236093
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2005-10-07
Brief Title:
Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain
Sponsor:
Cephalon
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A 4-week Open-Label Extension Study of ACTIQ Oral Transmucosal Fentanyl Citrate OTFC Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain
Status:
COMPLETED
Status Verified Date:
2014-05
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 objective of the study is to monitor the safety adverse event data of longer-term use of ACTIQ Oral Transmucosal Fentanyl Citrate OTFC treatment in children with pain associated with cancer sickle cell disease or severe burns and breakthrough pain BTP who are receiving around the clock ATC opioid therapy
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