Fentanyl for Treatment Pain Caused by Radiotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00523887|
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : April 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Fentanyl transdermal therapeutic system||Phase 4|
The study is a phase IV, open label, single arm study. The purpose of this study is to assess the clinical utility and safety of fentanyl transdermal therapeutic system (patch) for treatment of pain caused by radiotherapy. The patients increase or even decrease the amount of study medication in order to achieve pain relief, 48 to 72 hours or 3 days are required after the first patch application. The study medication will be used for 4 weeks. VAS (visual analog scale), BPI Q9 (quality of life) and global assessment have been used to assess the effectiveness. VAS will be assessed every week. BPI Q9 will be assessed at week 1 and week 4. Global assessment will be assessed at week 4. The safety of the study drug will be evaluated using adverse event (AE) report.
The investigator will assess the pain intensity of patients and increase or even decrease Fentanyl dosage every week. Fentanyl will be started on 25 or 50 ug per hr depending on investigator's judgement. Fentanyl will be administered for 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||163 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post-Marketing Surveillance of Durogesic for Treatment Pain Caused by Radiotherapy|
|Study Start Date :||August 2005|
|Actual Study Completion Date :||September 2006|
- To evaluate the clinical utility of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy. VAS (at week 1~4), BPI Q9 (week 1 and 4) and global assessment (week 4) have been used to assess the clinical utility.
- To evaluate the safety of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy using AE (adverse event) report at every visit.
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): NCT00523887
|Study Director:||Johnson & Johnson Taiwan, Ltd. Clinical Trial||Johnson & Johnson Taiwan Ltd|