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| Sponsor: | Johnson & Johnson Taiwan Ltd |
|---|---|
| Information provided by: | Johnson & Johnson Taiwan Ltd |
| ClinicalTrials.gov Identifier: | NCT00523887 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Fentanyl transdermal therapeutic system |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Post-Marketing Surveillance of Durogesic for Treatment Pain Caused by Radiotherapy |
| Enrollment: | 163 |
| Study Start Date: | August 2005 |
| Study Completion Date: | September 2006 |
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00523887 History of Changes |
| Other Study ID Numbers: | CR013990 |
| Study First Received: | August 30, 2007 |
| Last Updated: | April 26, 2010 |
| Health Authority: | Taiwan: Department of Health |
|
Radiation pain Duragesic Fentanyl Pain |
|
Fentanyl Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
