Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT00345735
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2006-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intranasal Fentanyl for the Treatment of Breakthrough Pain in Cancer Patients (FT-017-IM)
Sponsor:
Nycomed
Organization:
Study Overview
Official Title:
Intranasal Fentanyl for the Treatment of Breakthrough Pain in Cancer Patients. A Randomised, Double-blind, Placebo-controlled, Cross-over Confirmatory Trial Testing Fentanyl and Placebo in Eight Breakthrough Pain Episodes
Status:
COMPLETED
Status Verified Date:
2012-05
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:
Primary Objective:
To demonstrate the efficacy of intranasal fentanyl in the treatment of breakthrough pain (BTP) in cancer patients.
Secondary Objective:
To explore the relationship between the response to the fentanyl dose and the stable background pain opioid dose.
To demonstrate the efficacy of intranasal fentanyl in the treatment of breakthrough pain (BTP) in cancer patients.
Secondary Objective:
To explore the relationship between the response to the fentanyl dose and the stable background pain opioid dose.
Detailed Description:
None
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 |
|---|---|---|---|---|
| 2005-002347-82 | None | None | View |