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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 30, 2007 | ||||
| Last Updated Date | April 30, 2009 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00523887 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To evaluate the safety of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy using AE (adverse event) report at every visit. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fentanyl for Treatment Pain Caused by Radiotherapy | ||||
| Official Title ICMJE | Post-Marketing Surveillance of Durogesic for Treatment Pain Caused by Radiotherapy | ||||
| Brief 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 µ receptors. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Drug: Fentanyl transdermal therapeutic system | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 163 | ||||
| Completion Date | September 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00523887 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CR013990 | ||||
| Study Sponsor ICMJE | Johnson & Johnson Taiwan Ltd | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Johnson & Johnson Taiwan Ltd | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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