Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216658
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2005-09-13
Brief Title:
Phase II Clinical Trial of Fentanyl Transdermal Matrix Patch in the Management of Cancer Pain- Assessment of Effectiveness Safety and Pharmacokinetics -
Sponsor:
Janssen Pharmaceutical KK
Organization:
Janssen Pharmaceutical KK
Study Overview
Official Title:
Open Label Study to Confirm Effectiveness Safety and Pharmacokinetics of Fentanyl Transdermal Matrix Patch in Japanese Patients With Cancer Pain Who Have Had a Minimum Amount of Morphine Therapy Such as Equal to Less Than 45 mgDay of Oral Morphine or Oxycodone Equal to Less Than 30 mgDay
Status:
COMPLETED
Status Verified Date:
2011-01
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:
The purpose of this study is to verify the effectiveness safety and pharmacokinetics of fentanyl transdermal matrix patches containing either 125 mcghr 25 mcghr or 50 mcghr in Japanese patients with cancer pain who have been switched from minimum amount of existing morphine preparations such as equivalent to less than 45 mgday of oral morphine or oral oxycodone preparations equivalent to less than 30 mgday
Detailed Description:
Fentanyl transdermal matrix patch is a narcotic analgesic agent Compared with the existing reservoir-type Durotep Patch it is not liable to leakage of drug solution and does not contain alcohol which becomes a cause of skin irritation Also this new formulation becomes available of smaller one of 125 mcghr while the smallest Durotep Patch is 25 mcghr This clinical trial was planned to assess effectiveness safety and pharmacokinetics of fentanyl transdermal matrix patch at an initial transdermal dose of 125 mcg in Japanese cancer patients with pain receiving morphine preparations equivalent to less than 45 mgday of oral morphine less than 30 mg for suppository less than 15 mg for injection oral oxycodone preparations equivalent to less than 30 mgday or fentanyl citrate injectable solution equivalent to less than 03 mgday After pre-treatment period for one to three days for evaluating the eligibility of the patients for the study patients will use 3 patches for 10 days Starting from the first day of treatment with 125 mcghr patch fentanyl will be applied to the chest the upper arm or other appropriate site which will be replaced with a new patch every three days ca 72 hr Total treatment duration is ten days and dose adjustment can be allowed
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