An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics
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|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|
|Actual Primary Completion Date :||February 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|