NCT Number: NCT00523887
Fentanyl 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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
19 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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 outcomes
-
To evaluate the safety of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy using AE (adverse event) report at every visit.
Sponsors and collaborators
Lead sponsor
Johnson & Johnson Taiwan Ltd
Industry
Registry information
Official study title
Post-Marketing Surveillance of Durogesic for Treatment Pain Caused by Radiotherapy
Important dates
- Study start
- 2005
- Study completion
- 2006
- First posted
- Sep 3, 2007
- Registry last updated
- Apr 28, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Brief Mindfulness Intervention for Patients at a Free Acute Care Clinic
NCT07025161
Neurologic Manifestations, Pain
Orlando, Florida, United States
View Trial DetailsPectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement
NCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsPain Neuroscience Education for Middle School Students
NCT06869369
Behavior, Motor Activity
Kütahya, Turkey (Türkiye)
View Trial DetailsEffectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients
NCT07729020
Anxiety, Anxiety Disorders
Genoa, Liguria, Italy
View Trial Details