Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT01901718
Status:
TERMINATED
Last Update Posted:
2014-09-04
First Post:
2013-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.
Sponsor:
International Clinical Research Institute
Organization:
Study Overview
Official Title:
An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray Compared to Actiq® for the Management of Breakthrough Pain in Chronic Pain Patients.
Status:
TERMINATED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment was more challenging than anticipated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic pain patients who experience breakthrough pain in the background of controlled persistent pain with opioids will be followed for 3 months in order to assess the safety and titration trends in the clinical practice setting of a novel fentanyl sublingual spray (Subsys™) for the treatment of breakthrough pain.
Detailed Description:
Approximately 100 subjects across 10 centers throughout the United States will be enrolled into the study. Subjects who are currently taking Actiq® for their breakthrough pain and will be discontinued due to lack of efficacy, poor tolerability, patient or prescriber dissatisfaction and meet all other study inclusion criteria and none of the exclusion criteria will be candidates to receive a sublingual fentanyl spray (Subsys™). The total duration of the study for each subject will be no more than 4 months.
Study Oversight
Has Oversight DMC:
False
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?: