Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216684
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2005-09-13
Brief Title:
Phase III Clinical Trial of Fentanyl Transdermal Matrix Patch in the Management of Chronic Intractable Pain- Assessment of Effectiveness Safety and Pharmacokinetics
Sponsor:
Janssen Pharmaceutical KK
Organization:
Janssen Pharmaceutical KK
Study Overview
Official Title:
An Open Label Study to Confirm the Effectiveness and Safety of Fentanyl Transdermal Matrix Patch in Japanese Patients With Chronic Intractable Pain Who Has Prior Therapy of Codeine Morphine Hydrochloride or Fentanyl Injectable Preparations
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 and safety in Japanese patients with chronic intractable pain after 4-week medication of fentanyl transdermal matrix patches containing either 125 mcghr 25 mcghr 50 mcghr 75 mcghr or 100 mcghr who have been switched from existing formulations such as codeine morphine hydrochloride or fentanyl injectable Furthermore the safety and effectiveness of long term treatment such as 48 weeks are to be assessed if possible
Detailed Description:
Fentanyl transdermal matrix patch is a narcotic analgesic agent Compared with the existing reservoir-type Durotep Patch fentanyl transdermal matrix patch is not liable to leakage of drug solution and does not contain alcohol which becomes a cause of skin irritation Also this new formulation has become available in a smaller dose of 125mghr while the smallest Durotep Patch is 25mghr While Durotep Patch is currently indicated only for cancer pain in Japan this clinical trial was planned to assess effectiveness and safety of fentanyl transdermal matrix patch in Japanese patients with chronic intractable pain receiving codeine morphine hydrochloride or fentanyl injectable formulations After pre-treatment period for seven to fourteen days for evaluating the eligibility of the patients for the study patients will be treated for 4 weeks as Treatment period 1 and 48 weeks as Treatment period 2 followed by 3-day post-treatment observation period One patch can be used for 72 hours which is the same as the existing Patch Starting from the first day of treatment 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 Starting dose should be between 125 mcghr and 75 mcghr depending on the prior opioid dose
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