Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263575
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2005-12-07
Brief Title:
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients
Sponsor:
Kyowa Kirin Co Ltd
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
A Multiple-Dose Non-Randomized Open-Label Multicenter Study to Evaluate the Long-Term Safety and Effectiveness of EN3267 in the Treatment of Breakthrough Pain in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2024-06
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 long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid cancer patients who are using stable doses of opioid medication
Detailed Description:
This was a Phase 3 non-randomized open-label multicentre study designed to evaluate the long-term safety of EN3267 in the treatment of BTcP in opioid-tolerant cancer patients The study was conducted in 2 parts
1 A Titration Period during which patients had up to 2 weeks to determine a single effective dose of study medication EN3267 for adequate treatment of BTcP and
2 A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication
1 A Titration Period during which patients had up to 2 weeks to determine a single effective dose of study medication EN3267 for adequate treatment of BTcP and
2 A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication
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