An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics
|ClinicalTrials.gov Identifier: NCT01060124|
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : April 26, 2013
Last Update Posted : April 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pain; Cancer||Drug: Fentanyl D-trans||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids|
|Study Start Date :||April 2007|
|Primary Completion Date :||February 2009|
|Study Completion Date :||February 2009|
|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
- Percentage of Participants Satisfied With Pain Treatment [ Time Frame: Day 29 ]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 ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060124
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|