Ignite Creation Date:
2025-12-18 @ 8:14 AM
Ignite Modification Date:
2025-12-18 @ 8:14 AM
Study NCT ID:
NCT01060124
Status:
None
Last Update Posted:
2014-04-29 00:00:00
First Post:
2010-01-29 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics
Sponsor:
None
Organization:
Study Overview
Official Title:
Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids
Status:
None
Status Verified Date:
2014-04
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 an open-label (all people know the identity of the intervention), single-arm, multicenter (conducted in more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl D-trans in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics and for participant's satisfaction. The participants will receive the initial dose of TTS-fentanyl D-trans patch releasing 12 micrograms per hour (12 mcg/hr) of fentanyl and will be increased by 12 mcg/hr or 25 mcg/hr, every 3 days depending on the participant's pain control. Efficacy will primarily be evaluated by participant's satisfaction with pain treatment. Participant's safety will be monitored throughout the study.
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?: