NCT00523887

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Aug 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
Last Updated

April 28, 2010

Status Verified

April 1, 2010

First QC Date

August 30, 2007

Last Update Submit

April 26, 2010

Conditions

Pain

Keywords

Radiation painDuragesicFentanylPain

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

Interventions

Fentanyl transdermal therapeutic systemDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Johnson & Johnson Taiwan, Ltd. Clinical Trial

    Johnson & Johnson Taiwan Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2007

First Posted

September 3, 2007

Study Start

August 1, 2005

Study Completion

September 1, 2006

Last Updated

April 28, 2010

Record last verified: 2010-04