Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236327
Status:
TERMINATED
Last Update Posted:
2011-05-17
First Post:
2005-10-07
Brief Title:
Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain
Sponsor:
Janssen Cilag SAS
Organization:
Janssen Cilag SAS
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Transdermal Fentanyl in Patients Suffering From Chronic Cancer Pain in an Ambulatory Setting
Status:
TERMINATED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor discontinued the study following the discovery of a number of incompletely sealed batches that were unusable
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 determine the safety and efficacy of pain control by fentanyl administered via adhesive skin patches at doses of 25 to 100 micrograms per hour in 80 out-patients with intense chronic cancer pain Higher doses are allowed by permission of the investigator and rescue oral morphine medication is allowed
Detailed Description:
Patients with cancer pain are frequently under-medicated with morphine This is a 56-day open-label study of the efficacy and safety of self-administered fentanyl skin patches for cancer pain control in patients in the home-care setting not previously using morphine The first 15 days of the study are for dose stabilization and the rest of the study assesses pain control and quality of life at stable doses of medication The dose is determined by the patient with oversight by the investigator and rescue oral morphine medication can be used when necessary The patient records all medication use in a diary and fills out questionnaires concerning pain control intestinal function constipation and overall quality of life The hypothesis is that patients will be able to control their cancer pain by self-administering transdermal fentanyl at home and that they will well tolerate the medication
Individualized doses with a target dose of 25 to 100 micrograms per hour of fentanyl for 56 days via skin patches applied every 3 days to deliver 25 to 100 micrograms of fentanyl per hour per patch oral morphine as rescue medication for pain
Individualized doses with a target dose of 25 to 100 micrograms per hour of fentanyl for 56 days via skin patches applied every 3 days to deliver 25 to 100 micrograms of fentanyl per hour per patch oral morphine as rescue medication for pain
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