Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT00216658
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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 K.K.
Organization:
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 mg/Day of Oral Morphine or Oxycodone Equal to Less Than 30 mg/Day.
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 12.5 mcg/hr, 25 mcg/hr, or 50 mcg/hr in Japanese patients with cancer pain who have been switched from minimum amount of existing morphine preparations, such as equivalent to less than 45 mg/day of oral morphine, or oral oxycodone preparations equivalent to less than 30 mg/day.
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 12.5 mcg/hr while the smallest Durotep® Patch is 25 mcg/hr. This clinical trial was planned to assess effectiveness, safety and pharmacokinetics of fentanyl transdermal matrix patch at an initial transdermal dose of 12.5 mcg in Japanese cancer patients with pain receiving morphine preparations equivalent to less than 45 mg/day of oral morphine (less than 30 mg for suppository, less than 15 mg for injection), oral oxycodone preparations equivalent to less than 30 mg/day, or fentanyl citrate injectable solution equivalent to less than 0.3 mg/day. 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 12.5 mcg/hr 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: