Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT00538850
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2007-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
Sponsor:
INSYS Therapeutics Inc
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain
Status:
COMPLETED
Status Verified Date:
2014-01
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:
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. Patients are titrated to an effective-dose of fentanyl sublingual spray in the open-label titration period and then proceed to the double-blind randomized period where they randomly receive 7 treatments with fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods).
Detailed Description:
RATIONALE
Fentanyl sublingual spray may help relieve breakthrough pain in patients receiving opioids for cancer pain.
OBJECTIVES
Primary
* Determine the efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in patients on around-the-clock opioids for their persistent cancer pain.
Secondary
* Evaluate the safety of fentanyl sublingual spray in these opioid-tolerant patients.
* Assess the patient's satisfaction with treatment medication.
Fentanyl sublingual spray may help relieve breakthrough pain in patients receiving opioids for cancer pain.
OBJECTIVES
Primary
* Determine the efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in patients on around-the-clock opioids for their persistent cancer pain.
Secondary
* Evaluate the safety of fentanyl sublingual spray in these opioid-tolerant patients.
* Assess the patient's satisfaction with treatment medication.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDR0000581128 | REGISTRY | PDQ (Physician Data Query) | View |