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Fentanyl for Treatment Pain Caused by Radiotherapy
This study has been completed.
Study NCT00523887   Information provided by Johnson & Johnson Taiwan Ltd
First Received: August 30, 2007   Last Updated: April 30, 2009   History of Changes

August 30, 2007
April 30, 2009
August 2005
 
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.
Same as current
Complete list of historical versions of study NCT00523887 on ClinicalTrials.gov Archive Site
To evaluate the safety of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy using AE (adverse event) report at every visit.
Same as current
 
Fentanyl for Treatment Pain Caused by Radiotherapy
Post-Marketing Surveillance of Durogesic for Treatment Pain Caused by Radiotherapy

The purpose of this study is to assess the clinical utility and safety of Fentanyl for pain treatment caused by radiotherapy. Fentanyl is a synthetic pure opioid agonist with a selective activity on µ receptors.

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.

Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Pain
Drug: Fentanyl transdermal therapeutic system
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
163
September 2006
 

Inclusion Criteria:

  • Patients have the history of head and neck tumor
  • Patients who are proceeding radiotherapy
  • Patients who are administered weak opioids and pain score (Visual analog scale) of 4

Exclusion Criteria:

  • Patients who have been administered Fentanyl for pain treatment within 2 weeks before the study
  • Patients who will have surgery within 1 month
  • Known presence of distant metastasis
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00523887
 
CR013990
Johnson & Johnson Taiwan Ltd
 
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
Johnson & Johnson Taiwan Ltd
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP