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Fentanyl for Treatment Pain Caused by Radiotherapy

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT00523887
First received: August 30, 2007
Last updated: April 26, 2010
Last verified: April 2010

August 30, 2007
April 26, 2010
August 2005
Not Provided
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
Not Provided
Not Provided
 
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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: Fentanyl transdermal therapeutic system
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
September 2006
Not Provided

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
Not Provided
 
NCT00523887
CR013990
Not Provided
Not Provided
Johnson & Johnson Taiwan Ltd
Not Provided
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
Johnson & Johnson Taiwan Ltd
April 2010

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