An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics
The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) treatment in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and participant's satisfaction.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids|
- Percentage of Participants Satisfied With Pain Treatment [ Time Frame: Day 29 ] [ Designated as safety issue: No ]Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.
- Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans [ Time Frame: Day 1 and Day 29 ] [ Designated as safety issue: No ]Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain.
- Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment [ Time Frame: Day 29 ] [ Designated as safety issue: No ]Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other.
- Initial and End Point Dose of TTS-Fentanyl D-trans [ Time Frame: Day 1 and Day 29 ] [ Designated as safety issue: No ]Dose of TTS-fentanyl D-trans were monitored at start and end of the trial.
- Number of Participants With Investigator's Overall Evaluation on the Pain Treatment [ Time Frame: Day 29 ] [ Designated as safety issue: No ]Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied.
|Study Start Date:||April 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
|Experimental: Transdermal Therapeutic System (TTS)-Fentanyl D-trans||
Drug: Fentanyl D-trans
Fentanyl D-trans will be applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Other Name: Durogesic D-Trans
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060124
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|