Fentanyl for Treatment Pain Caused by Radiotherapy - Full Text View

Sponsored by:	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

MedlinePlus related topics: Radiation Therapy

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Post-Marketing Surveillance of Durogesic for Treatment Pain Caused by Radiotherapy

Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:

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 Measures:

To evaluate the safety of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy using AE (adverse event) report at every visit.

Enrollment:	163
Study Start Date:	August 2005
Study Completion Date:	September 2006

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

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523887

Sponsors and Collaborators

Johnson & Johnson Taiwan Ltd

Investigators

Study Director:

Johnson & Johnson Taiwan, Ltd. Clinical Trial

Johnson & Johnson Taiwan Ltd

More Information

No publications provided

Study ID Numbers:	CR013990
Study First Received:	August 30, 2007
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00523887 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Johnson & Johnson Taiwan Ltd:

Radiation pain
Duragesic
Fentanyl
Pain

Study placed in the following topic categories:

Anesthetics, Intravenous
Fentanyl
Anesthetics, General
Adjuvants, Immunologic
Central Nervous System Depressants
Anesthetics

Narcotics
Pain
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Anesthetics, Intravenous
Fentanyl
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009