Fentanyl for Treatment Pain Caused by Radiotherapy
Information source: Johnson & Johnson Taiwan Ltd
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Fentanyl transdermal therapeutic system (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Johnson & Johnson Taiwan Ltd Official(s) and/or principal investigator(s):
Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Taiwan Ltd
Summary
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 ยต receptors.
Clinical Details
Official title: Post-Marketing Surveillance of Durogesic for Treatment Pain Caused by Radiotherapy
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: To evaluate the safety of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy using AE (adverse event) report at every visit.
Detailed description:
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.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: August 2005
Ending date: September 2006
Last updated: October 19, 2007
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