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Evaluation of the Usefulness of DurogesicD-TRANS for Pain Treatment in Lung Cancer Patients

Phase 4
18 Years
Not Enrolling
Lung Cancer, Pain

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Trial Information

Evaluation of the Usefulness of DurogesicD-TRANS for Pain Treatment in Lung Cancer Patients

This study is open-label, single-arm, multicenter, prospective study to evaluate the
usefulness of fentanyl matrix (fentanyl transdermal patch-type system) by assessing patient
satisfaction when administrating fentanyl matrix (a background pain treatment, and a
breakthrough pain treatment) for patients with lung cancer for 21 days. Fentanyl
transdermal patch-type system is designed to deliver medication at a nearly constant amount
per unit time into the body through the skin for 3 days (72 hours). Studies about
transdermal fentanyl have found that it had analgesic effects on malignant pain, and most
patients receiving the medication preferred fentanyl because they experienced less
constipation. Safety assessments will include adverse event monitoring, vital signs,
laboratory work. starting with 12.5g/h or 25g/h of fentanyl matrix transdermally at the
investigator's discretion and flexible dose depending the patient's pain relief for 3 weeks

Inclusion Criteria:

- Patients with histologically confirmed lung cancer, who complain of cancer pain

- Patients who are taking Ultracet, Tramadol, or Codeine (or Codeine combination drug)
for cancer pain-relief purposes, but still complain of a pain level of 4 or above on
the Numeric Rating Scale (NRS) during the past 24 hours: Ultracet 3 tablets/day,
Tramadol 150 mg/day, Codeine 200 mg /day, or Codeine combination less than 3

- Patients who are able to communicate with the investigator about his/her pain

- Patients who use proper contraceptives during the study period if they are women of
childbearing potential

- Patients whose life expectancy is 3 months or longer

- Patients who have signed an informed consent form

Exclusion Criteria:

- Patients participating in other clinical trials

- Patients with a history of hypersensitivity to opioid analgesics

- Patients with a history of drug abuse

- Patients who are unable to use a transdermal product due to skin disease

- Patient with a history of CO2 retention (e.g. chronic obstructive pulmonary disease)

- Patients who are receiving radiotherapy or chemotherapy when registering for the
study or who plan to receive it during the study

- Patient who are pregnant or are of childbearing potential and not using

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient's satisfaction with pain treatment as measured by 5-point verbal scale

Outcome Time Frame:

Day 1, 8 and 22

Safety Issue:


Principal Investigator

Janssen Korea, Ltd. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Korea, Ltd.


Korea: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

May 2007

Related Keywords:

  • Lung Cancer
  • Pain
  • fentanyl matrix
  • Lung Neoplasms